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NCT03930381
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Adapting and Expanding the Algorithmic Software Tool to Help Manage Asthma (ASTHMAXcel) for Youth With Asthma
Brief Summary: This project seeks to test and refine an adapted/expanded version of a previously created ASTHMAXcel app.
|
{
"A": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Tailored Web-based Asthma Management | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Generic web-based asthma education | Intervention Type: BEHAVIORAL; Name: Tailored Web-based Asthma Management; Assigned to Arm(s): 1 | Intervention Type: BEHAVIORAL; Name: Generic web-based asthma education; Assigned to Arm(s): 2",
"B": "Arm Label: CHESS + Case Mgt; Type: EXPERIMENTAL; Interventions: Behavioral: CHESS Internet telehealth | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: CHESS Internet telehealth; Assigned to Arm(s): CHESS + Case Mgt",
"C": "Arm Label: Reference; Type: OTHER; Interventions: Behavioral: Marketed experience application on adherence | Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Marketed experience application on adherence | Intervention Type: BEHAVIORAL; Name: Marketed experience application on adherence; Assigned to Arm(s): Intervention, Reference",
"D": "Arm Label: Intervention Arm; Type: EXPERIMENTAL; Interventions: Other: ASTHMAXcel App | Arm Label: Usual Care Arm; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: ASTHMAXcel App; Assigned to Arm(s): Intervention Arm"
}
|
D
|
[
"NCT00201058",
"NCT00214383",
"NCT03951714",
"NCT03930381"
] | 27,200 |
val
|
NCT03935997
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Implementing, Evaluating, and Scaling Up of the Strengthening a Palliative Approach in Long Term Care (SPA-LTC) Program
Brief Summary: This study will evaluate the implementation of the Strengthening a Palliative Approach in Long-Term Care (SPA-LTC) program using a cross-jurisdictional, effectiveness-implementation type II hybrid design (dual testing of clinical and implementation interventions) to assess the implementation (feasibility, fidelity, reach, sustainability) and effectiveness (family satisfaction, staff knowledge and confidence implementing a palliative approach to care, hospital use).
|
{
"A": "Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Other: Strengthening a Palliative Approach in Long-Term Care (SPA-LTC) Program | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Strengthening a Palliative Approach in Long-Term Care (SPA-LTC) Program; Assigned to Arm(s): Intervention",
"B": "Arm Label: Intervention group; Type: OTHER; Interventions: Other: MultiDisciplinary Team Meetings (MDTM) | Arm Label: control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: MultiDisciplinary Team Meetings (MDTM); Assigned to Arm(s): Intervention group",
"C": "Arm Label: INH (Intervention Nursing Homes); Type: EXPERIMENTAL; Interventions: Other: TIME | Arm Label: CNH (Control Nursing Homes); Type: ACTIVE_COMPARATOR; Interventions: Other: Education-only intervention | Intervention Type: OTHER; Name: TIME; Assigned to Arm(s): INH (Intervention Nursing Homes) | Intervention Type: OTHER; Name: Education-only intervention; Assigned to Arm(s): CNH (Control Nursing Homes)",
"D": "Arm Label: Intervention group; Type: EXPERIMENTAL; Interventions: Behavioral: ACP+ programme | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: ACP+ programme; Assigned to Arm(s): Intervention group"
}
|
A
|
[
"NCT03935997",
"NCT01569997",
"NCT02655003",
"NCT03521206"
] | 27,201 |
val
|
NCT03936010
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Replication of Canagliflozin and Cardiovascular and Renal Events in Type 2 Diabetes (CANVAS Trial)
Brief Summary: Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
|
{
"A": "Arm Label: Clopidogrel 75 mg; Type: N/A; Interventions: Drug: Clopidogrel 75mg | Arm Label: Ticagrelor 90 mg; Type: N/A; Interventions: Drug: Ticagrelor 90mg | Intervention Type: DRUG; Name: Ticagrelor 90mg; Assigned to Arm(s): Ticagrelor 90 mg | Intervention Type: DRUG; Name: Clopidogrel 75mg; Assigned to Arm(s): Clopidogrel 75 mg",
"B": "Arm Label: DPP4i; Type: N/A; Interventions: Drug: DPP-4 inhibitor | Arm Label: Empagliflozin; Type: N/A; Interventions: Drug: Empagliflozin | Intervention Type: DRUG; Name: Empagliflozin; Assigned to Arm(s): Empagliflozin | Intervention Type: DRUG; Name: DPP-4 inhibitor; Assigned to Arm(s): DPP4i",
"C": "Arm Label: DPP4i; Type: N/A; Interventions: Drug: DPP-4 inhibitor | Arm Label: Canagliflozin; Type: N/A; Interventions: Drug: Canagliflozin | Intervention Type: DRUG; Name: Canagliflozin; Assigned to Arm(s): Canagliflozin | Intervention Type: DRUG; Name: DPP-4 inhibitor; Assigned to Arm(s): DPP4i",
"D": "Arm Label: 2nd generation sulfonylureas; Type: N/A; Interventions: Drug: Sulfonylurea | Arm Label: Linagliptin; Type: N/A; Interventions: Drug: Linagliptin | Intervention Type: DRUG; Name: Linagliptin; Assigned to Arm(s): Linagliptin | Intervention Type: DRUG; Name: Sulfonylurea; Assigned to Arm(s): 2nd generation sulfonylureas"
}
|
C
|
[
"NCT04237935",
"NCT04215536",
"NCT03936010",
"NCT03936036"
] | 27,202 |
val
|
NCT03936023
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Replication of the SAVOR-TIMI Diabetes Trial in Healthcare Claims
Brief Summary: Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
|
{
"A": "Arm Label: Clopidogrel 75 mg; Type: N/A; Interventions: Drug: Clopidogrel 75mg | Arm Label: Prasugrel 10 mg; Type: N/A; Interventions: Drug: Prasugrel 10mg | Intervention Type: DRUG; Name: Prasugrel 10mg; Assigned to Arm(s): Prasugrel 10 mg | Intervention Type: DRUG; Name: Clopidogrel 75mg; Assigned to Arm(s): Clopidogrel 75 mg",
"B": "Arm Label: Linagliptin; Type: N/A; Interventions: N/A | Arm Label: Glimepiride; Type: N/A; Interventions: N/A",
"C": "Arm Label: 2nd generation sulfonylureas; Type: N/A; Interventions: Drug: Sulfonylurea | Arm Label: Linagliptin; Type: N/A; Interventions: Drug: Linagliptin | Intervention Type: DRUG; Name: Linagliptin; Assigned to Arm(s): Linagliptin | Intervention Type: DRUG; Name: Sulfonylurea; Assigned to Arm(s): 2nd generation sulfonylureas",
"D": "Arm Label: 2nd Generation SUs; Type: N/A; Interventions: Drug: Sulfonylurea | Arm Label: Saxagliptin; Type: N/A; Interventions: Drug: Saxagliptin | Intervention Type: DRUG; Name: Saxagliptin; Assigned to Arm(s): Saxagliptin | Intervention Type: DRUG; Name: Sulfonylurea; Assigned to Arm(s): 2nd Generation SUs"
}
|
D
|
[
"NCT04237922",
"NCT03648424",
"NCT03936036",
"NCT03936023"
] | 27,203 |
val
|
NCT03936036
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Replication of the CARMELINA Diabetes Trial in Healthcare Claims
Brief Summary: Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
|
{
"A": "Arm Label: 2nd Generation SUs; Type: N/A; Interventions: Drug: Sulfonylurea | Arm Label: Sitagliptin; Type: N/A; Interventions: Drug: Sitagliptin | Intervention Type: DRUG; Name: Sitagliptin; Assigned to Arm(s): Sitagliptin | Intervention Type: DRUG; Name: Sulfonylurea; Assigned to Arm(s): 2nd Generation SUs",
"B": "Arm Label: 2nd generation sulfonylureas; Type: N/A; Interventions: Drug: Sulfonylurea | Arm Label: Linagliptin; Type: N/A; Interventions: Drug: Linagliptin | Intervention Type: DRUG; Name: Linagliptin; Assigned to Arm(s): Linagliptin | Intervention Type: DRUG; Name: Sulfonylurea; Assigned to Arm(s): 2nd generation sulfonylureas",
"C": "Arm Label: DPP4i; Type: N/A; Interventions: Drug: DPP-4 inhibitor | Arm Label: Empagliflozin; Type: N/A; Interventions: Drug: Empagliflozin | Intervention Type: DRUG; Name: Empagliflozin; Assigned to Arm(s): Empagliflozin | Intervention Type: DRUG; Name: DPP-4 inhibitor; Assigned to Arm(s): DPP4i",
"D": "Arm Label: Dapagliflozin; Type: N/A; Interventions: Drug: Dapagliflozin | Arm Label: DPP-4 inhibitor; Type: N/A; Interventions: Drug: DPP-4 inhibitor | Intervention Type: DRUG; Name: Dapagliflozin; Assigned to Arm(s): Dapagliflozin | Intervention Type: DRUG; Name: DPP-4 inhibitor; Assigned to Arm(s): DPP-4 inhibitor"
}
|
B
|
[
"NCT03936062",
"NCT03936036",
"NCT04215536",
"NCT04215523"
] | 27,204 |
val
|
NCT03936049
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Replication of the LEADER Diabetes Trial in Healthcare Claims
Brief Summary: Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
|
{
"A": "Arm Label: Clopidogrel 75 mg; Type: N/A; Interventions: Drug: Clopidogrel 75mg | Arm Label: Prasugrel 10 mg; Type: N/A; Interventions: Drug: Prasugrel 10mg | Intervention Type: DRUG; Name: Prasugrel 10mg; Assigned to Arm(s): Prasugrel 10 mg | Intervention Type: DRUG; Name: Clopidogrel 75mg; Assigned to Arm(s): Clopidogrel 75 mg",
"B": "Arm Label: Linagliptin; Type: N/A; Interventions: N/A | Arm Label: Glimepiride; Type: N/A; Interventions: N/A",
"C": "Arm Label: DPP-4 inhibitor; Type: N/A; Interventions: Drug: DPP-4 inhibitor | Arm Label: Liraglutide; Type: N/A; Interventions: Drug: Liraglutide | Intervention Type: DRUG; Name: Liraglutide; Assigned to Arm(s): Liraglutide | Intervention Type: DRUG; Name: DPP-4 inhibitor; Assigned to Arm(s): DPP-4 inhibitor",
"D": "Arm Label: DPP4i; Type: N/A; Interventions: Drug: DPP-4 inhibitor | Arm Label: Empagliflozin; Type: N/A; Interventions: Drug: Empagliflozin | Intervention Type: DRUG; Name: Empagliflozin; Assigned to Arm(s): Empagliflozin | Intervention Type: DRUG; Name: DPP-4 inhibitor; Assigned to Arm(s): DPP4i"
}
|
C
|
[
"NCT04237922",
"NCT03648424",
"NCT03936049",
"NCT04215536"
] | 27,205 |
val
|
NCT03936062
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Replication of the TECOS Diabetes Trial in Healthcare Claims
Brief Summary: Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
|
{
"A": "Arm Label: 2nd Generation SUs; Type: N/A; Interventions: Drug: Sulfonylurea | Arm Label: Sitagliptin; Type: N/A; Interventions: Drug: Sitagliptin | Intervention Type: DRUG; Name: Sitagliptin; Assigned to Arm(s): Sitagliptin | Intervention Type: DRUG; Name: Sulfonylurea; Assigned to Arm(s): 2nd Generation SUs",
"B": "Arm Label: DPP4i; Type: N/A; Interventions: Drug: DPP-4 inhibitor | Arm Label: Empagliflozin; Type: N/A; Interventions: Drug: Empagliflozin | Intervention Type: DRUG; Name: Empagliflozin; Assigned to Arm(s): Empagliflozin | Intervention Type: DRUG; Name: DPP-4 inhibitor; Assigned to Arm(s): DPP4i",
"C": "Arm Label: 2nd generation sulfonylureas; Type: N/A; Interventions: Drug: Sulfonylurea | Arm Label: Linagliptin; Type: N/A; Interventions: Drug: Linagliptin | Intervention Type: DRUG; Name: Linagliptin; Assigned to Arm(s): Linagliptin | Intervention Type: DRUG; Name: Sulfonylurea; Assigned to Arm(s): 2nd generation sulfonylureas",
"D": "Arm Label: DPP4i; Type: N/A; Interventions: Drug: DPP-4 inhibitor | Arm Label: Canagliflozin; Type: N/A; Interventions: Drug: Canagliflozin | Intervention Type: DRUG; Name: Canagliflozin; Assigned to Arm(s): Canagliflozin | Intervention Type: DRUG; Name: DPP-4 inhibitor; Assigned to Arm(s): DPP4i"
}
|
A
|
[
"NCT03936062",
"NCT04215536",
"NCT03936036",
"NCT03936010"
] | 27,206 |
val
|
NCT03937219
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Randomized, Double-Blind, Controlled Phase 3 Study of Cabozantinib in Combination With Nivolumab and Ipilimumab Versus Nivolumab and Ipilimumab in Subjects With Previously Untreated Advanced or Metastatic Renal Cell Carcinoma of Intermediate or Poor Risk
Brief Summary: This is a multicenter, randomized, double-blinded, controlled Phase 3 trial of cabozantinib in combination with nivolumab and ipilimumab versus nivolumab and ipilimumab in combination with matched placebo. Approximately 840 eligible subjects with intermediate- or poor-risk advanced or metastatic RCC by IMDC criteria will be randomized in a 1:1 ratio at approximately 180 sites.
|
{
"A": "Arm Label: Cabozantinib (XL184); Type: EXPERIMENTAL; Interventions: Drug: Cabozantinib tablets | Arm Label: Everolimus (Afinitor); Type: ACTIVE_COMPARATOR; Interventions: Drug: Everolimus (Afinitor) tablets | Intervention Type: DRUG; Name: Cabozantinib tablets; Assigned to Arm(s): Cabozantinib (XL184) | Intervention Type: DRUG; Name: Everolimus (Afinitor) tablets; Assigned to Arm(s): Everolimus (Afinitor)",
"B": "Arm Label: Experimental Arm; Type: EXPERIMENTAL; Interventions: Drug: Cabozantinib, Biological: Nivolumab, Biological: Ipilimumab | Arm Label: Control Arm; Type: ACTIVE_COMPARATOR; Interventions: Biological: Nivolumab, Biological: Ipilimumab, Drug: Cabozantinib-matched placebo | Intervention Type: DRUG; Name: Cabozantinib; Assigned to Arm(s): Experimental Arm | Intervention Type: BIOLOGICAL; Name: Nivolumab; Assigned to Arm(s): Control Arm, Experimental Arm | Intervention Type: BIOLOGICAL; Name: Ipilimumab; Assigned to Arm(s): Control Arm, Experimental Arm | Intervention Type: DRUG; Name: Cabozantinib-matched placebo; Assigned to Arm(s): Control Arm",
"C": "Arm Label: Arm A: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab, Biological: Ipilimumab | Arm Label: Arm B: Sunitinib 50 mg; Type: ACTIVE_COMPARATOR; Interventions: Biological: Nivolumab, Biological: Ipilimumab, Drug: Sunitinib | Intervention Type: BIOLOGICAL; Name: Nivolumab; Assigned to Arm(s): Arm A: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg, Arm B: Sunitinib 50 mg | Intervention Type: BIOLOGICAL; Name: Ipilimumab; Assigned to Arm(s): Arm A: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg, Arm B: Sunitinib 50 mg | Intervention Type: DRUG; Name: Sunitinib; Assigned to Arm(s): Arm B: Sunitinib 50 mg",
"D": "Arm Label: Lenvatinib; Type: EXPERIMENTAL; Interventions: Drug: Lenvatinib | Arm Label: Lenvatinib plus Everolimus; Type: EXPERIMENTAL; Interventions: Drug: Lenvatinib, Drug: Everolimus | Arm Label: Everolimus; Type: ACTIVE_COMPARATOR; Interventions: Drug: Everolimus | Intervention Type: DRUG; Name: Lenvatinib; Assigned to Arm(s): Lenvatinib, Lenvatinib plus Everolimus | Intervention Type: DRUG; Name: Everolimus; Assigned to Arm(s): Everolimus, Lenvatinib plus Everolimus"
}
|
B
|
[
"NCT01865747",
"NCT03937219",
"NCT02231749",
"NCT01136733"
] | 27,207 |
val
|
NCT03938103
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Hybrid Effectiveness-implementation Trial of Go NAPSACC: A Childcare-based Obesity Prevention Program
Brief Summary: This study will compare the effectiveness and cost of Basic and Enhanced delivery models for Go NAPSACC on child care centers' use of evidence-based nutrition and physical activity practices. Technical assistance (TA) coaches from Child Care Aware of Kentucky will lead delivery. Half of the TA coaches will deliver Go NAPSACC using the Basic model and the other half will deliver the program using the Enhanced model. It is hypothesized that the Enhanced model will result in greater use of evidence-based nutrition and physical activity practices and will also be more cost effective.
|
{
"A": "Arm Label: Program SI! educational intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Program SI! educational intervention | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Program SI! educational intervention; Assigned to Arm(s): Program SI! educational intervention",
"B": "Arm Label: Early Responders to Low Intensity; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Low Intensity | Arm Label: Non-Responders Continue Low Intensity; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Low Intensity | Arm Label: Non-Responders Increasing to High Intensity; Type: EXPERIMENTAL; Interventions: Behavioral: Low Intensity, Behavioral: High Intensity | Intervention Type: BEHAVIORAL; Name: Low Intensity; Assigned to Arm(s): Early Responders to Low Intensity, Non-Responders Continue Low Intensity, Non-Responders Increasing to High Intensity | Intervention Type: BEHAVIORAL; Name: High Intensity; Assigned to Arm(s): Non-Responders Increasing to High Intensity",
"C": "Arm Label: Enhanced Go NAPSACC; Type: EXPERIMENTAL; Interventions: Behavioral: Enhanced Go NAPSACC | Arm Label: Basic Go NAPSACC; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Basic Go NAPSACC | Intervention Type: BEHAVIORAL; Name: Enhanced Go NAPSACC; Assigned to Arm(s): Enhanced Go NAPSACC | Intervention Type: BEHAVIORAL; Name: Basic Go NAPSACC; Assigned to Arm(s): Basic Go NAPSACC",
"D": "Arm Label: Train-the-Trainers Arm; Type: EXPERIMENTAL; Interventions: Behavioral: Healthy Caregivers- Healthy Children Toolkit | Arm Label: Attention Control Arm; Type: OTHER; Interventions: Behavioral: Safety Curriculum | Intervention Type: BEHAVIORAL; Name: Healthy Caregivers- Healthy Children Toolkit; Assigned to Arm(s): Train-the-Trainers Arm | Intervention Type: BEHAVIORAL; Name: Safety Curriculum; Assigned to Arm(s): Attention Control Arm"
}
|
C
|
[
"NCT01579708",
"NCT05050539",
"NCT03938103",
"NCT02697565"
] | 27,208 |
val
|
NCT03938103
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Hybrid Effectiveness-implementation Trial of Go NAPSACC: A Childcare-based Obesity Prevention Program
Brief Summary: This study will compare the effectiveness and cost of Basic and Enhanced delivery models for Go NAPSACC on child care centers' use of evidence-based nutrition and physical activity practices. Technical assistance (TA) coaches from Child Care Aware of Kentucky will lead delivery. Half of the TA coaches will deliver Go NAPSACC using the Basic model and the other half will deliver the program using the Enhanced model. It is hypothesized that the Enhanced model will result in greater use of evidence-based nutrition and physical activity practices and will also be more cost effective.
|
{
"A": "Arm Label: Enhanced Go NAPSACC; Type: EXPERIMENTAL; Interventions: Behavioral: Enhanced Go NAPSACC | Arm Label: Basic Go NAPSACC; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Basic Go NAPSACC | Intervention Type: BEHAVIORAL; Name: Enhanced Go NAPSACC; Assigned to Arm(s): Enhanced Go NAPSACC | Intervention Type: BEHAVIORAL; Name: Basic Go NAPSACC; Assigned to Arm(s): Basic Go NAPSACC",
"B": "Arm Label: Early Responders to Low Intensity; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Low Intensity | Arm Label: Non-Responders Continue Low Intensity; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Low Intensity | Arm Label: Non-Responders Increasing to High Intensity; Type: EXPERIMENTAL; Interventions: Behavioral: Low Intensity, Behavioral: High Intensity | Intervention Type: BEHAVIORAL; Name: Low Intensity; Assigned to Arm(s): Early Responders to Low Intensity, Non-Responders Continue Low Intensity, Non-Responders Increasing to High Intensity | Intervention Type: BEHAVIORAL; Name: High Intensity; Assigned to Arm(s): Non-Responders Increasing to High Intensity",
"C": "Arm Label: Standard Palatability and Standard Portion Size; Type: EXPERIMENTAL; Interventions: Other: Plain Vegetables Served in 100% Portion Size | Arm Label: Standard Palatability and Larger Portion Size; Type: EXPERIMENTAL; Interventions: Other: Plain Vegetables Served in 200% Portion Size | Arm Label: Enhanced Palatability and Standard Portion Size; Type: EXPERIMENTAL; Interventions: Other: Enhanced Vegetables Served in 100% Portion Size | Arm Label: Enhanced Palatability and Larger Portion Size; Type: EXPERIMENTAL; Interventions: Other: Enhanced Vegetables Served in 200% Portion Size | Intervention Type: OTHER; Name: Plain Vegetables Served in 100% Portion Size; Assigned to Arm(s): Standard Palatability and Standard Portion Size | Intervention Type: OTHER; Name: Plain Vegetables Served in 200% Portion Size; Assigned to Arm(s): Standard Palatability and Larger Portion Size | Intervention Type: OTHER; Name: Enhanced Vegetables Served in 100% Portion Size; Assigned to Arm(s): Enhanced Palatability and Standard Portion Size | Intervention Type: OTHER; Name: Enhanced Vegetables Served in 200% Portion Size; Assigned to Arm(s): Enhanced Palatability and Larger Portion Size",
"D": "Arm Label: Treatment; Type: EXPERIMENTAL; Interventions: Other: Childhood Obesity | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Childhood Obesity; Assigned to Arm(s): Treatment"
}
|
A
|
[
"NCT03938103",
"NCT05050539",
"NCT03926065",
"NCT01722032"
] | 27,209 |
val
|
NCT03938103
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Hybrid Effectiveness-implementation Trial of Go NAPSACC: A Childcare-based Obesity Prevention Program
Brief Summary: This study will compare the effectiveness and cost of Basic and Enhanced delivery models for Go NAPSACC on child care centers' use of evidence-based nutrition and physical activity practices. Technical assistance (TA) coaches from Child Care Aware of Kentucky will lead delivery. Half of the TA coaches will deliver Go NAPSACC using the Basic model and the other half will deliver the program using the Enhanced model. It is hypothesized that the Enhanced model will result in greater use of evidence-based nutrition and physical activity practices and will also be more cost effective.
|
{
"A": "Intervention Type: BEHAVIORAL; Name: Physical activity and diet; Assigned to Arm(s): N/A",
"B": "Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Control | Arm Label: Email and 4 Home Visits; Type: EXPERIMENTAL; Interventions: Behavioral: Emails and 4 Home Visits | Arm Label: Email and 2 Home Visits; Type: EXPERIMENTAL; Interventions: Behavioral: Emails and 2 home visits | Intervention Type: BEHAVIORAL; Name: Emails and 4 Home Visits; Assigned to Arm(s): Email and 4 Home Visits | Intervention Type: BEHAVIORAL; Name: Control; Assigned to Arm(s): Control | Intervention Type: BEHAVIORAL; Name: Emails and 2 home visits; Assigned to Arm(s): Email and 2 Home Visits",
"C": "Arm Label: NOURISH-T; Type: EXPERIMENTAL; Interventions: Behavioral: NOURISH-T | Arm Label: Enhanced Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Enhanced Usual Care | Intervention Type: BEHAVIORAL; Name: NOURISH-T; Assigned to Arm(s): NOURISH-T | Intervention Type: BEHAVIORAL; Name: Enhanced Usual Care; Assigned to Arm(s): Enhanced Usual Care",
"D": "Arm Label: Enhanced Go NAPSACC; Type: EXPERIMENTAL; Interventions: Behavioral: Enhanced Go NAPSACC | Arm Label: Basic Go NAPSACC; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Basic Go NAPSACC | Intervention Type: BEHAVIORAL; Name: Enhanced Go NAPSACC; Assigned to Arm(s): Enhanced Go NAPSACC | Intervention Type: BEHAVIORAL; Name: Basic Go NAPSACC; Assigned to Arm(s): Basic Go NAPSACC"
}
|
D
|
[
"NCT00107692",
"NCT02223234",
"NCT02815982",
"NCT03938103"
] | 27,210 |
val
|
NCT03939507
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Prospective Study on Long-term Outcome and Potential Usefulness fo an Intervention Aimed at Reducing Adverse Effects in Patients With Refractory Epilepsy
Brief Summary: Over 1 million people in the European Union (EU) suffer from chronic refractory epilepsy. Their quality of life (QoL) is severely affected by seizures and by the adverse effect of antiepileptic drug (AED) treatment. Several new AEDs have been introduced in recent years, but their impact on the long-term outcome in these patients has been inadequately explored. Preliminary data from the U.S. suggests that using a standardize toll to quantitate adverse AED effects can improve outcome, but the general applicability of these findings is unclear.
Objectives: 1) To assess prospectively AED utilization patterns in patients with refractory epilepsy ; 2) to assess how such treatments and other variables correlated with seizure control, adverse effects, and QoL in these patients; 3) to establish the impact of a standardized evaluation of adverse effects on clinical outcome.
Methods: The project included a core observational study and a randomized intervention in a subcohort.
In the core (observational) study, 1,000 consecutive refractory epilepsy patients were enrolled and followed-up prospectively at 10 centres in Italy. The following parameters were recorded at 0 (entry), 6, 12 and 18 months: (i) drug therapy; (ii) seizure frequency; (iii) adverse events based on medical examination and non-structured interview; (iii) treatment costs and, (iv) for patients above age 16, standardized questionnaires for adverse effects (AEP), depressive symptoms (Becks Depression Scale, BDS), QoL (QOLIE-31) and clinical global impression (CGI). The primary outcome (changes in QOLIE-31 scores) will be related to the other variables measured.
In the randomized intervention, the subcohort meeting specific eligibility criteria (age \>16 years, no progressive disorder, AEP score\>=45 ) was randomized to two groups. In the intervention group, AEP score results were made available to the physician at each visit, while in the other group AEP scores were only made available at the end of follow-up. Primary outcome were changes in AEP score.
|
{
"A": "Arm Label: A; Type: EXPERIMENTAL; Interventions: Behavioral: Questioners | Arm Label: B; Type: EXPERIMENTAL; Interventions: Behavioral: STAR website | Intervention Type: BEHAVIORAL; Name: Questioners; Assigned to Arm(s): A | Intervention Type: BEHAVIORAL; Name: STAR website; Assigned to Arm(s): B",
"B": "Arm Label: Intervention group; Type: EXPERIMENTAL; Interventions: Other: AEP score available to the treating physician | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: AEP score available to the treating physician; Assigned to Arm(s): Intervention group",
"C": "Arm Label: Personal counseling; Type: EXPERIMENTAL; Interventions: Behavioral: Personal Counseling | Arm Label: Computer generated feedback letters; Type: EXPERIMENTAL; Interventions: Behavioral: Computer-generated feedback letters | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Personal Counseling; Assigned to Arm(s): Personal counseling | Intervention Type: BEHAVIORAL; Name: Computer-generated feedback letters; Assigned to Arm(s): Computer generated feedback letters",
"D": "Arm Label: Arm 1; Type: EXPERIMENTAL; Interventions: Behavioral: HITCM+CP | Arm Label: Arm 2; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: HITCM only | Intervention Type: BEHAVIORAL; Name: HITCM+CP; Assigned to Arm(s): Arm 1 | Intervention Type: BEHAVIORAL; Name: HITCM only; Assigned to Arm(s): Arm 2"
}
|
B
|
[
"NCT00578006",
"NCT03939507",
"NCT01291693",
"NCT00555360"
] | 27,211 |
val
|
NCT03941886
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Implementation of First-trimester Screening and Prevention of Preeclampsia: a Stepped Wedge Cluster-randomized Trial in Asia
Brief Summary: This implementation study aims to evaluate the efficacy, acceptability, and safety of first-trimester screening and prevention for preterm-preeclampsia. It is a multicenter stepped wedge cluster randomized trial including maternity / diagnostic units from ten regions in Asia. The study involves a period where no intervention will take place at all recruiting units, and then at regular intervals, one cluster will be randomized to transit from non-intervention group to intervention group in which first-trimester screening for preterm-preeclampsia by the Bayes based method followed by the commencement of low-dose aspirin in high-risk women.
|
{
"A": "Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Acetylsalicylic acid | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Acetylsalicylic acid; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2",
"B": "Arm Label: Non-intervention group; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Intervention group; Type: EXPERIMENTAL; Interventions: Other: Low-dose aspirin in women with high risk of preeclampsia | Intervention Type: OTHER; Name: Low-dose aspirin in women with high risk of preeclampsia; Assigned to Arm(s): Intervention group",
"C": "Arm Label: Intervention Arm; Type: ACTIVE_COMPARATOR; Interventions: Drug: Low dose aspirin | Arm Label: Placebo Arm; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Low dose aspirin; Assigned to Arm(s): Intervention Arm | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo Arm",
"D": "Arm Label: aspirin; Type: EXPERIMENTAL; Interventions: Drug: Aspirin | Arm Label: blank; Type: OTHER; Interventions: Other: Blank | Intervention Type: DRUG; Name: Aspirin; Assigned to Arm(s): aspirin | Intervention Type: OTHER; Name: Blank; Assigned to Arm(s): blank"
}
|
B
|
[
"NCT00683202",
"NCT03941886",
"NCT02409680",
"NCT02797249"
] | 27,212 |
val
|
NCT03942718
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Internet-based Supervised Exercise Program in Systemic Lupus Erythematosus: A Randomized Controlled Trial
Brief Summary: This pilot study is a randomized controlled trial to assess the effect of an individualized supervised exercise program in patients with systemic lupus erythematosus (SLE) compared to treatment-as-usual (TAU).
|
{
"A": "Arm Label: Exercise; Type: EXPERIMENTAL; Interventions: Behavioral: Exercise training | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Healthy control; Type: EXPERIMENTAL; Interventions: Behavioral: Exercise training | Intervention Type: BEHAVIORAL; Name: Exercise training; Assigned to Arm(s): Exercise, Healthy control",
"B": "Arm Label: EXERCISE GROUP; Type: EXPERIMENTAL; Interventions: Behavioral: HAND EXERCISE | Arm Label: CONTROL GROUP; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: HAND EXERCISE; Assigned to Arm(s): EXERCISE GROUP",
"C": "Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Aerobic exercise group; Type: EXPERIMENTAL; Interventions: Other: Exercise | Arm Label: Anaerobic exercise group; Type: EXPERIMENTAL; Interventions: Other: Exercise | Intervention Type: OTHER; Name: Exercise; Assigned to Arm(s): Aerobic exercise group, Anaerobic exercise group",
"D": "Arm Label: Placebo plus SOC; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Belimumab 1 mg/kg plus SOC; Type: EXPERIMENTAL; Interventions: Drug: Belimumab 1 mg/kg | Arm Label: Belimumab 4 mg/kg plus SOC; Type: EXPERIMENTAL; Interventions: Drug: Belimumab 4 mg/kg | Arm Label: Belimumab 10 mg/kg plus SOC; Type: EXPERIMENTAL; Interventions: Drug: Belimumab 10 mg/kg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo plus SOC | Intervention Type: DRUG; Name: Belimumab 1 mg/kg; Assigned to Arm(s): Belimumab 1 mg/kg plus SOC | Intervention Type: DRUG; Name: Belimumab 4 mg/kg; Assigned to Arm(s): Belimumab 4 mg/kg plus SOC | Intervention Type: DRUG; Name: Belimumab 10 mg/kg; Assigned to Arm(s): Belimumab 10 mg/kg plus SOC"
}
|
C
|
[
"NCT01515163",
"NCT03802578",
"NCT03942718",
"NCT00071487"
] | 27,213 |
val
|
NCT03943862
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: To Share or Not To Share (2Share) - Group Intervention to Support Disclosure Decisions After Suicide Attempt
Brief Summary: The purpose of the study is to evaluate the group-based intervention "To Share Or Not To Share" in a German clinical setting. Feasibility and efficacy of the program will be tested in a pilot randomized-controlled trial.
|
{
"A": "Intervention Type: BEHAVIORAL; Name: Cognitive Therapy; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: Supportive Therapy; Assigned to Arm(s): N/A",
"B": "Arm Label: Intervention (2Share) + treatment as usual; Type: EXPERIMENTAL; Interventions: Behavioral: 2Share | Arm Label: Treatment as usual; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: 2Share; Assigned to Arm(s): Intervention (2Share) + treatment as usual",
"C": "Arm Label: ASAP Treatment and Brite; Type: EXPERIMENTAL; Interventions: Behavioral: As Safe As Possible, Behavioral: Brite | Arm Label: Treatment as Usual; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Treatment as Usual | Intervention Type: BEHAVIORAL; Name: As Safe As Possible; Assigned to Arm(s): ASAP Treatment and Brite | Intervention Type: BEHAVIORAL; Name: Brite; Assigned to Arm(s): ASAP Treatment and Brite | Intervention Type: BEHAVIORAL; Name: Treatment as Usual; Assigned to Arm(s): Treatment as Usual",
"D": "Arm Label: Study participants; Type: EXPERIMENTAL; Interventions: Other: EMA | Intervention Type: OTHER; Name: EMA; Assigned to Arm(s): Study participants"
}
|
B
|
[
"NCT00131781",
"NCT03943862",
"NCT02272179",
"NCT03720730"
] | 27,214 |
val
|
NCT03943862
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: To Share or Not To Share (2Share) - Group Intervention to Support Disclosure Decisions After Suicide Attempt
Brief Summary: The purpose of the study is to evaluate the group-based intervention "To Share Or Not To Share" in a German clinical setting. Feasibility and efficacy of the program will be tested in a pilot randomized-controlled trial.
|
{
"A": "Arm Label: S-DBT; Type: EXPERIMENTAL; Interventions: Behavioral: Standard dialectical behavior therapy (SDBT) | Arm Label: DBT-I; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Individual DBT with no DBT group sessions (DBT-I) | Arm Label: DBT-S; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Group Skills DBT with no DBT individual sessions (DBT-S) | Intervention Type: BEHAVIORAL; Name: Standard dialectical behavior therapy (SDBT); Assigned to Arm(s): S-DBT | Intervention Type: BEHAVIORAL; Name: Individual DBT with no DBT group sessions (DBT-I); Assigned to Arm(s): DBT-I | Intervention Type: BEHAVIORAL; Name: Group Skills DBT with no DBT individual sessions (DBT-S); Assigned to Arm(s): DBT-S",
"B": "Arm Label: Inpatient Adaptation of DBT; Type: EXPERIMENTAL; Interventions: Behavioral: Inpatient Adaptation of DBT | Arm Label: Outpatient DBT; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: standard outpatient DBT | Intervention Type: BEHAVIORAL; Name: standard outpatient DBT; Assigned to Arm(s): Outpatient DBT | Intervention Type: BEHAVIORAL; Name: Inpatient Adaptation of DBT; Assigned to Arm(s): Inpatient Adaptation of DBT",
"C": "Arm Label: Intervention (2Share) + treatment as usual; Type: EXPERIMENTAL; Interventions: Behavioral: 2Share | Arm Label: Treatment as usual; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: 2Share; Assigned to Arm(s): Intervention (2Share) + treatment as usual",
"D": "Arm Label: Immediate Functional Imagery Training (FIT); Type: EXPERIMENTAL; Interventions: Behavioral: Functional Imagery Training (FIT) | Arm Label: Delayed Functional Imagery Training (FIT); Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Functional Imagery Training (FIT); Assigned to Arm(s): Immediate Functional Imagery Training (FIT)"
}
|
C
|
[
"NCT00183651",
"NCT01904227",
"NCT03943862",
"NCT02914847"
] | 27,215 |
val
|
NCT03943862
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: To Share or Not To Share (2Share) - Group Intervention to Support Disclosure Decisions After Suicide Attempt
Brief Summary: The purpose of the study is to evaluate the group-based intervention "To Share Or Not To Share" in a German clinical setting. Feasibility and efficacy of the program will be tested in a pilot randomized-controlled trial.
|
{
"A": "Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Active group; Type: EXPERIMENTAL; Interventions: Behavioral: Psychotherapy | Intervention Type: BEHAVIORAL; Name: Psychotherapy; Assigned to Arm(s): Active group",
"B": "Arm Label: Intervention (2Share) + treatment as usual; Type: EXPERIMENTAL; Interventions: Behavioral: 2Share | Arm Label: Treatment as usual; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: 2Share; Assigned to Arm(s): Intervention (2Share) + treatment as usual",
"C": "Arm Label: TAU w/ mobile app + volunteer support; Type: EXPERIMENTAL; Interventions: Behavioral: Volunteer support, Other: Mobile app | Arm Label: TAU w/ mobile app engagement; Type: EXPERIMENTAL; Interventions: Other: Mobile app | Arm Label: Treatment as Usual (TAU); Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Volunteer support; Assigned to Arm(s): TAU w/ mobile app + volunteer support | Intervention Type: OTHER; Name: Mobile app; Assigned to Arm(s): TAU w/ mobile app + volunteer support, TAU w/ mobile app engagement",
"D": "Arm Label: Zero Suicide Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Zero Suicide Usual Care | Arm Label: Zero Suicide Usual Care + ASSIP; Type: EXPERIMENTAL; Interventions: Behavioral: Attempted Suicide Short Intervention Program | Intervention Type: BEHAVIORAL; Name: Attempted Suicide Short Intervention Program; Assigned to Arm(s): Zero Suicide Usual Care + ASSIP | Intervention Type: BEHAVIORAL; Name: Zero Suicide Usual Care; Assigned to Arm(s): Zero Suicide Usual Care"
}
|
B
|
[
"NCT00641498",
"NCT03943862",
"NCT03081078",
"NCT03894462"
] | 27,216 |
val
|
NCT03945123
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of Korea Red Ginseng on Non-alcoholic Fatty Liver Disease
Brief Summary: Korea Red Ginseng (KRG) has effect on liver function
|
{
"A": "Arm Label: Omega 3 recipient arm; Type: ACTIVE_COMPARATOR; Interventions: Drug: Omega 3 Fish Oil supplements | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Omega 3 Fish Oil supplements; Assigned to Arm(s): Omega 3 recipient arm | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"B": "Arm Label: VSL#3 placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: VSL#3 placebo | Arm Label: VSL#3 active probiotic; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: VSL#3 active probiotic | Intervention Type: DIETARY_SUPPLEMENT; Name: VSL#3 active probiotic; Assigned to Arm(s): VSL#3 active probiotic | Intervention Type: OTHER; Name: VSL#3 placebo; Assigned to Arm(s): VSL#3 placebo",
"C": "Arm Label: Lepicol probiotic & prebiotic formula+simple lifestyle advice; Type: ACTIVE_COMPARATOR; Interventions: Drug: Lepicol probiotic & prebiotic formula, Other: Simple lifestyle advice | Arm Label: Simple lifestyle advice alone; Type: PLACEBO_COMPARATOR; Interventions: Other: Simple lifestyle advice | Intervention Type: DRUG; Name: Lepicol probiotic & prebiotic formula; Assigned to Arm(s): Lepicol probiotic & prebiotic formula+simple lifestyle advice | Intervention Type: OTHER; Name: Simple lifestyle advice; Assigned to Arm(s): Lepicol probiotic & prebiotic formula+simple lifestyle advice, Simple lifestyle advice alone",
"D": "Arm Label: Ginseng trial; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Red ginseng | Intervention Type: DIETARY_SUPPLEMENT; Name: Red ginseng; Assigned to Arm(s): Ginseng trial"
}
|
D
|
[
"NCT00681408",
"NCT01650025",
"NCT00870012",
"NCT03945123"
] | 27,217 |
val
|
NCT03950076
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: EdoxabaN for IntraCranial Hemorrhage Survivors with Atrial Fibrillation (ENRICH-AF)
Brief Summary: To assess whether edoxaban (60/30 mg daily) compared to non-antithrombotic medical therapy (either no antithrombotic therapy or antiplatelet monotherapy) reduces the risk of stroke (composite of ischemic, hemorrhagic and unspecified stroke) or systemic embolism in high-risk atrial fibrillation (CHA2DS2-VASc ≥2) patients with previous intracranial hemorrhage.
|
{
"A": "Arm Label: Antithrombotic treatment; Type: EXPERIMENTAL; Interventions: Drug: Antithrombotic Agent | Arm Label: No antithrombotic treatment; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: Antithrombotic Agent; Assigned to Arm(s): Antithrombotic treatment",
"B": "Arm Label: Study I (AF); Type: N/A; Interventions: N/A | Arm Label: Study II (ICH); Type: N/A; Interventions: N/A",
"C": "Arm Label: Apixaban; Type: EXPERIMENTAL; Interventions: Drug: Apixaban | Arm Label: Avoiding oral anticoagulants; Type: OTHER; Interventions: Drug: Aspirin, Drug: Carbasalate calcium, Drug: Clopidogrel, Drug: Dipyridamole, Other: No antithrombotic treatment | Intervention Type: DRUG; Name: Apixaban; Assigned to Arm(s): Apixaban | Intervention Type: DRUG; Name: Aspirin; Assigned to Arm(s): Avoiding oral anticoagulants | Intervention Type: DRUG; Name: Carbasalate calcium; Assigned to Arm(s): Avoiding oral anticoagulants | Intervention Type: DRUG; Name: Clopidogrel; Assigned to Arm(s): Avoiding oral anticoagulants | Intervention Type: DRUG; Name: Dipyridamole; Assigned to Arm(s): Avoiding oral anticoagulants | Intervention Type: OTHER; Name: No antithrombotic treatment; Assigned to Arm(s): Avoiding oral anticoagulants",
"D": "Arm Label: Edoxaban 60/30mg daily; Type: EXPERIMENTAL; Interventions: Drug: Edoxaban | Arm Label: Non-anticoagulant medical therapy; Type: ACTIVE_COMPARATOR; Interventions: Other: Non-anticoagulant medical therapy | Intervention Type: DRUG; Name: Edoxaban; Assigned to Arm(s): Edoxaban 60/30mg daily | Intervention Type: OTHER; Name: Non-anticoagulant medical therapy; Assigned to Arm(s): Non-anticoagulant medical therapy"
}
|
D
|
[
"NCT03186729",
"NCT02513316",
"NCT02565693",
"NCT03950076"
] | 27,218 |
val
|
NCT03951714
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: 12-wks Randomised Controlled Trial to Explore the Effect of a Smartphone App. Connected to an Add-on Device System Fitted on pMDI Inhaler on Adherence to Medications Intake and Clinical Outcomes in Difficult-to-treat Asthmatic Patients
Brief Summary: The purpose of this Study is to assess the effect of a smartphone application connected to an add-on device system fitted on Pressured Metered Dose Inhaler (PMDI) on adherence to take medications as prescribed and clinical outcomes in difficult-to-treat asthmatic patients.
|
{
"A": "Arm Label: Reference; Type: OTHER; Interventions: Behavioral: Marketed experience application on adherence | Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Marketed experience application on adherence | Intervention Type: BEHAVIORAL; Name: Marketed experience application on adherence; Assigned to Arm(s): Intervention, Reference",
"B": "Arm Label: Intervention group; Type: EXPERIMENTAL; Interventions: Device: Spencer | Arm Label: Control Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Spencer; Assigned to Arm(s): Intervention group",
"C": "Arm Label: Standard Care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Text Messaging; Type: EXPERIMENTAL; Interventions: Behavioral: Text Messaging | Intervention Type: BEHAVIORAL; Name: Text Messaging; Assigned to Arm(s): Text Messaging",
"D": "Arm Label: Feedback and alarms; Type: EXPERIMENTAL; Interventions: Device: Activated Smartinhaler or Smartturbo, Other: Feedback of adherence data | Arm Label: No feedback or alarms; Type: ACTIVE_COMPARATOR; Interventions: Device: Deactivated Smartinhaler or Smartturbo | Intervention Type: DEVICE; Name: Activated Smartinhaler or Smartturbo; Assigned to Arm(s): Feedback and alarms | Intervention Type: OTHER; Name: Feedback of adherence data; Assigned to Arm(s): Feedback and alarms | Intervention Type: DEVICE; Name: Deactivated Smartinhaler or Smartturbo; Assigned to Arm(s): No feedback or alarms"
}
|
A
|
[
"NCT03951714",
"NCT04339296",
"NCT02176694",
"NCT02451709"
] | 27,219 |
val
|
NCT03951909
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of Physiotherapy and Psychological Group Treatment on Physical and Mental Health Among Refugees From Syria With Pain Disorders or Post-traumatic Symptoms
Brief Summary: The war in Syria began in 2011 and refugees from this country have faced stressors including security risks, lack of access and availability of basic services and resources as well as family, community, and socio political tensions. Exposure to stressful events or situations, either short or long lasting, of exceptionally threatening or catastrophic nature is likely to cause pervasive distress in almost anyone, which might disturb daily life function, integration in society and ability to function in work and society, although this stress does not necessarily need to become an established medical diagnose. For a long time now, somatic and mental health systems have been overburdened and inaccessible both in Syria and in transit countries, and there is little available evidence of the effect of interventions targeting common health problems among refugees once established in their host countries.
In this project, the University of Bergen, in close collaboration with the Centre for Migration Health (Bergen municipality) and the Centre for Crisis Psychology, have developed two treatment interventions that are both theoretically sound and practically scalable if shown to be effective.
Among resettled asylum seekers and refugees, the primary aim of the project is to separately study in a quantitative way the effect on both physical and mental health of two different interventions: Physiotherapy activity and awareness intervention for participants with pain disorders and Teaching recovery techniques for participants with post-traumatic symptoms In addition, in a qualitative mode, our secondary aim is to analyse the processes by which the interventions help/do not help the patients to improve their health. Last, as the third aim of the study, cost effectiveness analyses will be conducted.
|
{
"A": "Arm Label: Wait List Control Group; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Intervention Group; Type: EXPERIMENTAL; Interventions: Behavioral: Trauma Focused Cognitive Behavioral Therapy | Intervention Type: BEHAVIORAL; Name: Trauma Focused Cognitive Behavioral Therapy; Assigned to Arm(s): Intervention Group",
"B": "Arm Label: ARM 1: Component-Based Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Common Elements Treatment Approach | Arm Label: ARM 2: Community Group Therapy; Type: EXPERIMENTAL; Interventions: Behavioral: Narrative Community Group Therapy | Arm Label: ARM 3: Standby group; Type: OTHER; Interventions: Other: Standby group | Intervention Type: BEHAVIORAL; Name: Common Elements Treatment Approach; Assigned to Arm(s): ARM 1: Component-Based Intervention | Intervention Type: BEHAVIORAL; Name: Narrative Community Group Therapy; Assigned to Arm(s): ARM 2: Community Group Therapy | Intervention Type: OTHER; Name: Standby group; Assigned to Arm(s): ARM 3: Standby group",
"C": "Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Psychosocial support training for school teachers | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Psychosocial support training for school teachers; Assigned to Arm(s): Intervention",
"D": "Arm Label: Active intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Physiotherapy activity and awareness intervention: PAAI, Behavioral: Psychological intervention: Teaching recovery techniques (TRT) | Arm Label: Waiting list; Type: EXPERIMENTAL; Interventions: Behavioral: Physiotherapy activity and awareness intervention: PAAI, Behavioral: Psychological intervention: Teaching recovery techniques (TRT) | Intervention Type: BEHAVIORAL; Name: Physiotherapy activity and awareness intervention: PAAI; Assigned to Arm(s): Active intervention, Waiting list | Intervention Type: BEHAVIORAL; Name: Psychological intervention: Teaching recovery techniques (TRT); Assigned to Arm(s): Active intervention, Waiting list"
}
|
D
|
[
"NCT01624298",
"NCT01856673",
"NCT03387007",
"NCT03951909"
] | 27,220 |
val
|
NCT03953924
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effects of Transtheoretical Model-based Intervention and Motivational Interviewing on the Management of Depression in Hospitalized Patients With Coronary Heart Disease : A Randomized, Controlled Trial
Brief Summary: In the middle of this century, coronary heart disease (CHD) is the most common cause of death in the United States. Chinese health service survey showed that about 1000,0000 \~ 320,000 people were suffering from CHD in the mainland of China in 2008. The high mortality and morbidity of CHD will aggravate the psychological burden of patients, such as depression. Depression is the most psychological problem in CHD patients. The incidence of depression in Chinese population was in the range of 4%\~6%, while it was as high as 14%\~17% in patients with CHD. Depression not only affects the patients' illness, but also reducing their quality of life, the compliance of drugs and lifestyle. In addition, depression is a major risk factor for the mortality and morbidity of cardiovascular disease. Therefore, it's urgently needed to screen and treat the depression of patients with CHD.
At present, the treatment of depression in patients with CHD mainly includes antidepressant, cognitive behavioral therapy， psychological counseling, knowledge education, relaxation therapy and so on. However, the medicine would yield side - effect. Furthermore, the content of psychological interventions are not systematic and dynamic. Moreover, patients' depressive level varies in different periods, the traditional psychological intervention just focused on the ultimate psychological benefits, and cannot analyze some factors and staged results in the process of psycho-behavioral change. Thus, an dynamic and effective intervention to alleviate depression in patients with CHD is imperative.
|
{
"A": "Arm Label: ACT-based intervention; Type: EXPERIMENTAL; Interventions: Behavioral: ACT-based intervention, Behavioral: usual care | Arm Label: Usual care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: usual care | Intervention Type: BEHAVIORAL; Name: ACT-based intervention; Assigned to Arm(s): ACT-based intervention | Intervention Type: BEHAVIORAL; Name: usual care; Assigned to Arm(s): ACT-based intervention, Usual care",
"B": "Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Intervention group; Type: EXPERIMENTAL; Interventions: Other: Transtheoretical model-based (TTM - based) intervention and motivational interviewing (MI) | Intervention Type: OTHER; Name: Transtheoretical model-based (TTM - based) intervention and motivational interviewing (MI); Assigned to Arm(s): Intervention group",
"C": "Arm Label: Treatment; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Omega-3 Fatty Acid Supplement | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Omega-3 Fatty Acid Supplement; Assigned to Arm(s): Treatment | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo",
"D": "Arm Label: Escitalopram; Type: EXPERIMENTAL; Interventions: Drug: Escitalopram | Arm Label: Placebo pill; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Escitalopram; Assigned to Arm(s): Escitalopram | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo pill"
}
|
B
|
[
"NCT01909102",
"NCT03953924",
"NCT00981383",
"NCT00419471"
] | 27,221 |
val
|
NCT03953950
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of Add-on Spironolactone to Losartan Versus Losartan Alone on Peritoneal Membrane Among Continuous Ambulatory Peritoneal Dialysis Patients: An Open-Label Randomized-Controlled Trial
Brief Summary: The ESCAPE-PD (Effects of add-on SpironolaCtone to losartan versus Alone on Peritoneal mEmbrane among continuous ambulatory Peritoneal Dialysis patients) study is a randomized, open-label, single center, active-controlled clinical trial. Adults end-stage kidney disease patients 18 years or older undergoing continuous ambulatory peritoneal dialysis (CAPD) will be enrolled. A total 84 CAPD will be randomly assigned to either the combination of spironolactone and losartan (experimental arm) or losartan alone (control arm). The primary outcomes are the difference in peritoneal dialysate effluent cancer antigen-125 (CA-125) and peritoneal equilibration test (PET) indices (dialysate-to-plasma creatinine ratio, 4-hour ultrafiltration volume, and the concentration of glucose present in the solution at the start of the test). Secondary outcome measures include laboratory and mechanistic outcome measures, nutrition outcomes, health-related quality of life, physical function, clinical events, and safety profiles. Results will be disseminated to suggest a strategy to prevent the peritoneal membrane function among CAPD patients through peer-reviewed publications along with scientific meetings.
|
{
"A": "Arm Label: Eplerenone; Type: EXPERIMENTAL; Interventions: Drug: eplerenone | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: eplerenone; Assigned to Arm(s): Eplerenone | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"B": "Arm Label: Combination of spironolactone and losartan; Type: EXPERIMENTAL; Interventions: Drug: Spironolactone, Drug: Losartan | Arm Label: Losartan Alone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Losartan | Intervention Type: DRUG; Name: Spironolactone; Assigned to Arm(s): Combination of spironolactone and losartan | Intervention Type: DRUG; Name: Losartan; Assigned to Arm(s): Combination of spironolactone and losartan, Losartan Alone",
"C": "Arm Label: Spironolactone; Type: ACTIVE_COMPARATOR; Interventions: Drug: Spironolactone | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Spironolactone; Assigned to Arm(s): Spironolactone | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"D": "Arm Label: Spironolactone; Type: EXPERIMENTAL; Interventions: Drug: Spironolactone | Intervention Type: DRUG; Name: Spironolactone; Assigned to Arm(s): Spironolactone"
}
|
B
|
[
"NCT01650012",
"NCT03953950",
"NCT01691053",
"NCT01128101"
] | 27,222 |
val
|
NCT03954158
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 2b, Multi Center, Randomized, Double-Blind, Vehicle-Controlled, Intra-Participant Study, to Evaluate Efficacy and Safety of Two Regimens of Crisaborole Ointment 2% in Japanese Pediatric and Adult Participants (2 Years and Older) With Mild to Moderate Atopic Dermatitis
Brief Summary: This is a Phase 2b, multi-center, randomized, double-blind, vehicle-controlled, intraparticipant study to evaluate efficacy and safety of two regimens of crisaborole ointment 2% in Japanese pediatric and adult participants (cohort 1: 12 years and older, cohort 2: 2 to under 12 years old) with mild to moderate Atopic Dermatitis (AD).
|
{
"A": "Arm Label: Vehicle Control (VC) Period: Vehicle Cream BID; Type: PLACEBO_COMPARATOR; Interventions: Drug: Vehicle cream | Arm Label: VC Period: Ruxolitinib 0.75% Cream BID; Type: EXPERIMENTAL; Interventions: Drug: Ruxolitinib cream | Arm Label: VC Period: Ruxolitinib 1.5% Cream BID; Type: EXPERIMENTAL; Interventions: Drug: Ruxolitinib cream | Arm Label: Long-Term Safety (LTS) Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID; Type: EXPERIMENTAL; Interventions: Drug: Ruxolitinib cream | Arm Label: LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID; Type: EXPERIMENTAL; Interventions: Drug: Ruxolitinib cream | Arm Label: LTS Period: Ruxolitinib 0.75% Cream BID; Type: EXPERIMENTAL; Interventions: Drug: Ruxolitinib cream | Arm Label: LTS Period: Ruxolitinib 1.5% Cream BID; Type: EXPERIMENTAL; Interventions: Drug: Ruxolitinib cream | Intervention Type: DRUG; Name: Ruxolitinib cream; Assigned to Arm(s): LTS Period: Ruxolitinib 0.75% Cream BID, LTS Period: Ruxolitinib 1.5% Cream BID, LTS Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID, Long-Term Safety (LTS) Period: Vehicle Cream to Ruxolitinib 0.75% Cream BID, VC Period: Ruxolitinib 0.75% Cream BID, VC Period: Ruxolitinib 1.5% Cream BID | Intervention Type: DRUG; Name: Vehicle cream; Assigned to Arm(s): Vehicle Control (VC) Period: Vehicle Cream BID",
"B": "Arm Label: Dicillin & Elocon; Type: ACTIVE_COMPARATOR; Interventions: Drug: Dicloxacillin Oral Capsule, Drug: Elocon 0.1 % Topical Cream | Arm Label: Placebo & Elocon; Type: PLACEBO_COMPARATOR; Interventions: Drug: Elocon 0.1 % Topical Cream | Intervention Type: DRUG; Name: Dicloxacillin Oral Capsule; Assigned to Arm(s): Dicillin & Elocon | Intervention Type: DRUG; Name: Elocon 0.1 % Topical Cream; Assigned to Arm(s): Dicillin & Elocon, Placebo & Elocon",
"C": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: E6005 | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: E6005; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 2",
"D": "Arm Label: Crisaborole ointment 2% once daily (QD) vs vehicle QD; Type: EXPERIMENTAL; Interventions: Drug: Crisaborole ointment 2%, Drug: Vehicle | Arm Label: Crisaborole ointment 2% twice daily (BID) vs vehicle BID; Type: EXPERIMENTAL; Interventions: Drug: Crisaborole ointment 2%, Drug: Vehicle | Intervention Type: DRUG; Name: Crisaborole ointment 2%; Assigned to Arm(s): Crisaborole ointment 2% twice daily (BID) vs vehicle BID | Intervention Type: DRUG; Name: Vehicle; Assigned to Arm(s): Crisaborole ointment 2% twice daily (BID) vs vehicle BID | Intervention Type: DRUG; Name: Crisaborole ointment 2%; Assigned to Arm(s): Crisaborole ointment 2% once daily (QD) vs vehicle QD | Intervention Type: DRUG; Name: Vehicle; Assigned to Arm(s): Crisaborole ointment 2% once daily (QD) vs vehicle QD"
}
|
D
|
[
"NCT03745651",
"NCT05578482",
"NCT01179880",
"NCT03954158"
] | 27,223 |
val
|
NCT03956225
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction (MGD): A 12-month, Multicenter Study
Brief Summary: The purpose of this post-approval study is to demonstrate that iLux treatment offers comparable treatment effectiveness to LipiFlow for MGD treatment at 12 months post single treatment.
|
{
"A": "Arm Label: EyeGiene; Type: ACTIVE_COMPARATOR; Interventions: Device: EyeGiene | Arm Label: Blephasteam; Type: ACTIVE_COMPARATOR; Interventions: Device: Blephasteam | Arm Label: Control- Hot Compress; Type: PLACEBO_COMPARATOR; Interventions: Device: Hot compresses | Intervention Type: DEVICE; Name: Blephasteam; Assigned to Arm(s): Blephasteam | Intervention Type: DEVICE; Name: EyeGiene; Assigned to Arm(s): EyeGiene | Intervention Type: DEVICE; Name: Hot compresses; Assigned to Arm(s): Control- Hot Compress",
"B": "Arm Label: iLux; Type: EXPERIMENTAL; Interventions: Device: Systane iLux® Dry Eye System | Arm Label: LipiFlow; Type: ACTIVE_COMPARATOR; Interventions: Device: LipiFlow® Thermal Pulsation System | Intervention Type: DEVICE; Name: Systane iLux® Dry Eye System; Assigned to Arm(s): iLux | Intervention Type: DEVICE; Name: LipiFlow® Thermal Pulsation System; Assigned to Arm(s): LipiFlow",
"C": "Arm Label: TearCare; Type: EXPERIMENTAL; Interventions: Device: TearCare | Arm Label: LipiFlow; Type: ACTIVE_COMPARATOR; Interventions: Device: LipiFlow | Intervention Type: DEVICE; Name: TearCare; Assigned to Arm(s): TearCare | Intervention Type: DEVICE; Name: LipiFlow; Assigned to Arm(s): LipiFlow",
"D": "Arm Label: Normal; Type: N/A; Interventions: N/A | Arm Label: Dry Eye Disease; Type: N/A; Interventions: N/A"
}
|
B
|
[
"NCT01448369",
"NCT03956225",
"NCT03857919",
"NCT00848198"
] | 27,224 |
val
|
NCT03957395
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Comparison of Effectiveness of Tonic, High Frequency and Burst Spinal Cord Stimulation in Chronic Pain Syndromes: a Double-blind, Randomised, Cross-over, Placebo Controlled Trial
Brief Summary: Spinal cord stimulation (SCS) is one of the most commonly undertaken neuromodulatory surgery techniques in the treatment of neuropathic pain. The indication for SCS is an ineffective conservative treatment of chronic pain syndromes. The effectiveness of SCS in the case of neuropathic pain is high. The positive result of SCS treatment is the reduction of previous painful symptoms by min. 50% and / or a reduction in the amount of taken analgesics and an improvement in the quality of life including sleep quality. Long-term studies estimate that in a properly selected group of patients more than 50% of patients achieve pain reduction by the required 50% and about 60% - 70% have an improvement in the quality of life and a reduction of pain.
The efficacy of SCS in different modes of stimulation is evaluated. Patients receive four different types of stimulation for 2-week period - not knowing what kind of stimulation it is. It is said that in one type of stimulation they would feel parestesias and in other three they would not. Patients are not informed that beside tonic, burst and high frequency stimulation, the fourth is an off stimulation to check for placebo effect. The test is double-blinded
|
{
"A": "Arm Label: Sequence 1; Type: OTHER; Interventions: Device: High frequency spinal cord stimulation | Arm Label: Sequence 2; Type: OTHER; Interventions: Device: High frequency spinal cord stimulation | Intervention Type: DEVICE; Name: High frequency spinal cord stimulation; Assigned to Arm(s): Sequence 1, Sequence 2",
"B": "Arm Label: scs high-frequency; Type: EXPERIMENTAL; Interventions: Device: Device: Precision Novi™ system Neurostimulation procedures | Arm Label: scs tonic; Type: EXPERIMENTAL; Interventions: Device: Device: Precision Novi™ system Neurostimulation procedures | Arm Label: scs burst; Type: EXPERIMENTAL; Interventions: Device: Device: Precision Novi™ system Neurostimulation procedures | Arm Label: scs off; Type: PLACEBO_COMPARATOR; Interventions: Device: Device: Precision Novi™ system Neurostimulation procedures | Intervention Type: DEVICE; Name: Device: Precision Novi™ system Neurostimulation procedures; Assigned to Arm(s): scs burst, scs high-frequency, scs off, scs tonic",
"C": "Arm Label: Burst spinal cord stimulation (SCS); Type: EXPERIMENTAL; Interventions: Procedure: Burst Spinal Cord Stimulation, Procedure: Sham spinal cord stimulation | Arm Label: sham spinal cord stimulation (SCS); Type: SHAM_COMPARATOR; Interventions: Procedure: Burst Spinal Cord Stimulation, Procedure: Sham spinal cord stimulation | Intervention Type: PROCEDURE; Name: Burst Spinal Cord Stimulation; Assigned to Arm(s): Burst spinal cord stimulation (SCS), sham spinal cord stimulation (SCS) | Intervention Type: PROCEDURE; Name: Sham spinal cord stimulation; Assigned to Arm(s): Burst spinal cord stimulation (SCS), sham spinal cord stimulation (SCS)",
"D": "Arm Label: Spinal Cord Stimulation; Type: EXPERIMENTAL; Interventions: Procedure: Spinal Cord Stimulation | Arm Label: Treatment as usual; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: PROCEDURE; Name: Spinal Cord Stimulation; Assigned to Arm(s): Spinal Cord Stimulation"
}
|
B
|
[
"NCT01400282",
"NCT03957395",
"NCT04039633",
"NCT01162993"
] | 27,225 |
val
|
NCT03957395
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Comparison of Effectiveness of Tonic, High Frequency and Burst Spinal Cord Stimulation in Chronic Pain Syndromes: a Double-blind, Randomised, Cross-over, Placebo Controlled Trial
Brief Summary: Spinal cord stimulation (SCS) is one of the most commonly undertaken neuromodulatory surgery techniques in the treatment of neuropathic pain. The indication for SCS is an ineffective conservative treatment of chronic pain syndromes. The effectiveness of SCS in the case of neuropathic pain is high. The positive result of SCS treatment is the reduction of previous painful symptoms by min. 50% and / or a reduction in the amount of taken analgesics and an improvement in the quality of life including sleep quality. Long-term studies estimate that in a properly selected group of patients more than 50% of patients achieve pain reduction by the required 50% and about 60% - 70% have an improvement in the quality of life and a reduction of pain.
The efficacy of SCS in different modes of stimulation is evaluated. Patients receive four different types of stimulation for 2-week period - not knowing what kind of stimulation it is. It is said that in one type of stimulation they would feel parestesias and in other three they would not. Patients are not informed that beside tonic, burst and high frequency stimulation, the fourth is an off stimulation to check for placebo effect. The test is double-blinded
|
{
"A": "Arm Label: scs high-frequency; Type: EXPERIMENTAL; Interventions: Device: Device: Precision Novi™ system Neurostimulation procedures | Arm Label: scs tonic; Type: EXPERIMENTAL; Interventions: Device: Device: Precision Novi™ system Neurostimulation procedures | Arm Label: scs burst; Type: EXPERIMENTAL; Interventions: Device: Device: Precision Novi™ system Neurostimulation procedures | Arm Label: scs off; Type: PLACEBO_COMPARATOR; Interventions: Device: Device: Precision Novi™ system Neurostimulation procedures | Intervention Type: DEVICE; Name: Device: Precision Novi™ system Neurostimulation procedures; Assigned to Arm(s): scs burst, scs high-frequency, scs off, scs tonic",
"B": "Arm Label: Burst spinal cord stimulation (SCS); Type: EXPERIMENTAL; Interventions: Procedure: Burst Spinal Cord Stimulation, Procedure: Sham spinal cord stimulation | Arm Label: sham spinal cord stimulation (SCS); Type: SHAM_COMPARATOR; Interventions: Procedure: Burst Spinal Cord Stimulation, Procedure: Sham spinal cord stimulation | Intervention Type: PROCEDURE; Name: Burst Spinal Cord Stimulation; Assigned to Arm(s): Burst spinal cord stimulation (SCS), sham spinal cord stimulation (SCS) | Intervention Type: PROCEDURE; Name: Sham spinal cord stimulation; Assigned to Arm(s): Burst spinal cord stimulation (SCS), sham spinal cord stimulation (SCS)",
"C": "Arm Label: High Frequency; Type: EXPERIMENTAL; Interventions: Device: Spinal Cord Stimulator HF | Arm Label: Sham; Type: SHAM_COMPARATOR; Interventions: Device: Spinal Cord Stimulator Sham | Intervention Type: DEVICE; Name: Spinal Cord Stimulator HF; Assigned to Arm(s): High Frequency | Intervention Type: DEVICE; Name: Spinal Cord Stimulator Sham; Assigned to Arm(s): Sham",
"D": "Arm Label: Spinal Cord Stimulation (SCS); Type: ACTIVE_COMPARATOR; Interventions: Device: Spinal Cord Stimulation | Arm Label: Conventional Medical Management (CMM); Type: ACTIVE_COMPARATOR; Interventions: Other: Conventional Medical Management | Intervention Type: DEVICE; Name: Spinal Cord Stimulation; Assigned to Arm(s): Spinal Cord Stimulation (SCS) | Intervention Type: OTHER; Name: Conventional Medical Management; Assigned to Arm(s): Conventional Medical Management (CMM)"
}
|
A
|
[
"NCT03957395",
"NCT04039633",
"NCT03312010",
"NCT04479787"
] | 27,226 |
val
|
NCT03957395
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Comparison of Effectiveness of Tonic, High Frequency and Burst Spinal Cord Stimulation in Chronic Pain Syndromes: a Double-blind, Randomised, Cross-over, Placebo Controlled Trial
Brief Summary: Spinal cord stimulation (SCS) is one of the most commonly undertaken neuromodulatory surgery techniques in the treatment of neuropathic pain. The indication for SCS is an ineffective conservative treatment of chronic pain syndromes. The effectiveness of SCS in the case of neuropathic pain is high. The positive result of SCS treatment is the reduction of previous painful symptoms by min. 50% and / or a reduction in the amount of taken analgesics and an improvement in the quality of life including sleep quality. Long-term studies estimate that in a properly selected group of patients more than 50% of patients achieve pain reduction by the required 50% and about 60% - 70% have an improvement in the quality of life and a reduction of pain.
The efficacy of SCS in different modes of stimulation is evaluated. Patients receive four different types of stimulation for 2-week period - not knowing what kind of stimulation it is. It is said that in one type of stimulation they would feel parestesias and in other three they would not. Patients are not informed that beside tonic, burst and high frequency stimulation, the fourth is an off stimulation to check for placebo effect. The test is double-blinded
|
{
"A": "Arm Label: HF/TCS/BURST; Type: EXPERIMENTAL; Interventions: Device: Precision Spectra™ system | Arm Label: HF/BURST/TCS; Type: EXPERIMENTAL; Interventions: Device: Precision Spectra™ system | Arm Label: BURST/HF/TCS; Type: EXPERIMENTAL; Interventions: Device: Precision Spectra™ system | Arm Label: BURST/TCS/HF; Type: EXPERIMENTAL; Interventions: Device: Precision Spectra™ system | Arm Label: TCS/BURST/HF; Type: EXPERIMENTAL; Interventions: Device: Precision Spectra™ system | Arm Label: TCS/HF/BURST; Type: EXPERIMENTAL; Interventions: Device: Precision Spectra™ system | Intervention Type: DEVICE; Name: Precision Spectra™ system; Assigned to Arm(s): BURST/HF/TCS, BURST/TCS/HF, HF/BURST/TCS, HF/TCS/BURST, TCS/BURST/HF, TCS/HF/BURST",
"B": "Intervention Type: DEVICE; Name: Spinal Cord Stimulation; Assigned to Arm(s): N/A",
"C": "Arm Label: Sham; Type: SHAM_COMPARATOR; Interventions: Device: Sham | Arm Label: 1200 Hz; Type: EXPERIMENTAL; Interventions: Device: 1200 Hz | Arm Label: 3030 Hz; Type: EXPERIMENTAL; Interventions: Device: 3030 Hz | Arm Label: 5882 Hz; Type: EXPERIMENTAL; Interventions: Device: 5882 Hz | Intervention Type: DEVICE; Name: Sham; Assigned to Arm(s): Sham | Intervention Type: DEVICE; Name: 1200 Hz; Assigned to Arm(s): 1200 Hz | Intervention Type: DEVICE; Name: 3030 Hz; Assigned to Arm(s): 3030 Hz | Intervention Type: DEVICE; Name: 5882 Hz; Assigned to Arm(s): 5882 Hz",
"D": "Arm Label: scs high-frequency; Type: EXPERIMENTAL; Interventions: Device: Device: Precision Novi™ system Neurostimulation procedures | Arm Label: scs tonic; Type: EXPERIMENTAL; Interventions: Device: Device: Precision Novi™ system Neurostimulation procedures | Arm Label: scs burst; Type: EXPERIMENTAL; Interventions: Device: Device: Precision Novi™ system Neurostimulation procedures | Arm Label: scs off; Type: PLACEBO_COMPARATOR; Interventions: Device: Device: Precision Novi™ system Neurostimulation procedures | Intervention Type: DEVICE; Name: Device: Precision Novi™ system Neurostimulation procedures; Assigned to Arm(s): scs burst, scs high-frequency, scs off, scs tonic"
}
|
D
|
[
"NCT03014583",
"NCT00200122",
"NCT01750229",
"NCT03957395"
] | 27,227 |
val
|
NCT03958019
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Rehabilitation Strategies Following Oesophagogastric and Hepatopancreaticobiliary Cancer (RESTORE II) - A Randomised Controlled Trial
Brief Summary: The RESTORE II randomized controlled trial will examine the efficacy of a 12 week multidisciplinary rehabilitation program consisting of supervised and home-based exercise,1:1 dietetic counselling, and group education sessions for survivors of upper gastrointestinal cancer, namely cancers of the oesophagus, stomach, pancreas, and liver.
|
{
"A": "Arm Label: Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Auto Plus; Type: ACTIVE_COMPARATOR; Interventions: Other: Auto Plus | Intervention Type: OTHER; Name: Auto Plus; Assigned to Arm(s): Auto Plus",
"B": "Arm Label: Control Group; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Intervention Group I; Type: EXPERIMENTAL; Interventions: Behavioral: self-regulation | Intervention Type: BEHAVIORAL; Name: self-regulation; Assigned to Arm(s): Intervention Group I",
"C": "Arm Label: Enrollment video arm; Type: EXPERIMENTAL; Interventions: Behavioral: Enrollment video | Arm Label: No video intervention arm; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: ULS; Type: EXPERIMENTAL; Interventions: Procedure: ULS | Arm Label: SSLF; Type: EXPERIMENTAL; Interventions: Procedure: SSLF | Arm Label: PMT; Type: EXPERIMENTAL; Interventions: Behavioral: PMT | Arm Label: Usual Care; Type: OTHER; Interventions: Other: Usual Care | Intervention Type: BEHAVIORAL; Name: Enrollment video; Assigned to Arm(s): Enrollment video arm | Intervention Type: PROCEDURE; Name: SSLF; Assigned to Arm(s): SSLF | Intervention Type: PROCEDURE; Name: ULS; Assigned to Arm(s): ULS | Intervention Type: BEHAVIORAL; Name: PMT; Assigned to Arm(s): PMT | Intervention Type: OTHER; Name: Usual Care; Assigned to Arm(s): Usual Care",
"D": "Arm Label: Intervention Group; Type: EXPERIMENTAL; Interventions: Other: RESTORE II Program | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: RESTORE II Program; Assigned to Arm(s): Intervention Group"
}
|
D
|
[
"NCT01742065",
"NCT01909349",
"NCT01166373",
"NCT03958019"
] | 27,228 |
val
|
NCT03959488
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)
Brief Summary: The purpose of this study is to evaluate the safety and tolerability of MEDI8897 compared to palivizumab when administered to preterm infants entering their first RSV season and children with chronic lung disease (CLD) and congenital heart disease (CHD) entering their first and second RSV season.
|
{
"A": "Arm Label: MEDI8897; Type: EXPERIMENTAL; Interventions: Drug: MEDI8897 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: MEDI8897; Assigned to Arm(s): MEDI8897 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"B": "Arm Label: Palivizumab; Type: ACTIVE_COMPARATOR; Interventions: Drug: Palivizumab | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: Palivizumab; Assigned to Arm(s): Palivizumab | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo",
"C": "Arm Label: MEDI8897; Type: EXPERIMENTAL; Interventions: Drug: MEDI8897 | Arm Label: Palivizumab; Type: ACTIVE_COMPARATOR; Interventions: Drug: Palivizumab | Intervention Type: DRUG; Name: MEDI8897; Assigned to Arm(s): MEDI8897 | Intervention Type: DRUG; Name: Palivizumab; Assigned to Arm(s): Palivizumab",
"D": "Arm Label: RSVpreF vaccine; Type: EXPERIMENTAL; Interventions: Biological: RSVpreF | Arm Label: Placebo dose; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo | Intervention Type: BIOLOGICAL; Name: RSVpreF; Assigned to Arm(s): RSVpreF vaccine | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): Placebo dose"
}
|
C
|
[
"NCT03979313",
"NCT02442427",
"NCT03959488",
"NCT04424316"
] | 27,229 |
val
|
NCT03959631
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effectiveness and Cost-effectiveness of a Virtual Intervention (VCoP) to Improve the Empowerment of Patients With Ischaemic Heart Disease in Primary Care: Cluster Randomized Controlled Trial
Brief Summary: Objective: to evaluate the effectiveness and estimate the costs of a Virtual Community of Practice in the improvement of the activation of patients with Ischemic Heart Disease in Primary Care .
Methods:
Design: pragmatic randomized controlled multicentric trial. Setting: health centres belonging to the Autonomous Communities of Catalonia, Madrid and the Canary Islands. Population: 246 patients with Ischemic Heart Disease in Primary Care. Randomization: randomization will be central and automatically performed by the online "e-mpodera" platform and the assigned group will be communicated to the patient once he or she has entered the platform and completed baseline assessment. Intervention: the intervention group will be offered participation for 6 months in a Virtual Community of Practice based on a web 2.0 platform in which there is interaction with other patients and with a multidisciplinary team of professionals. The intervention will be co-designed with a group of patients and a group of primary and specialized care professionals. The control group will receive usual care. Measurements: the main variable will be measured using the Patient Activation Measure questionnaire at baseline, 6, 12 and 18 months. Secondary variables: sociodemographic and clinical variables of the patients; knowledge test (questionnaire of risk cardiovascular factories , attitudes (Self-efficacy Managing Chronic Disease Scale ), adherence to Mediterranean diet (Mediterranean Diet), level of physical activity (International Physical Activity Questionnaire), medication adherence (Adherence Refill and Medication Scale (ARMS-e), depression (Patient Health Questionnaire), anxiety (Hospital Anxiety and Depression Scale), quality of life (EQ-5D-5L); variables related to the use of health resources; variables related to the use of the Virtual Community of Practice . Data will be collected from self-reported questionnaires and the electronic medical records. Analysis: a linear regression model of mixed effects will be estimated to estimate the effect of participating in the Virtual Community of Practice. In addition, subgroup analyses will be carried out and indicators of the functioning of the Virtual Community of Practice will be measured through techniques of Social Network Analysis and Control Charts. There will be an economic evaluation of the Virtual Community of Practice from the perspective of the National Health System and from the social perspective.
|
{
"A": "Arm Label: Enhanced Internet-based intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Tailored content, Behavioral: Generic Internet-based information, Behavioral: Discussion forum, Behavioral: Behavioral monitoring | Arm Label: Control; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Generic Internet-based information, Behavioral: Discussion forum | Intervention Type: BEHAVIORAL; Name: Tailored content; Assigned to Arm(s): Enhanced Internet-based intervention | Intervention Type: BEHAVIORAL; Name: Generic Internet-based information; Assigned to Arm(s): Control, Enhanced Internet-based intervention | Intervention Type: BEHAVIORAL; Name: Discussion forum; Assigned to Arm(s): Control, Enhanced Internet-based intervention | Intervention Type: BEHAVIORAL; Name: Behavioral monitoring; Assigned to Arm(s): Enhanced Internet-based intervention",
"B": "Arm Label: Peer-mentoring; Type: EXPERIMENTAL; Interventions: Other: Peer-mentoring | Intervention Type: OTHER; Name: Peer-mentoring; Assigned to Arm(s): Peer-mentoring",
"C": "Arm Label: Intervention group; Type: EXPERIMENTAL; Interventions: Behavioral: Virtual Communities of practice | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Virtual Communities of practice; Assigned to Arm(s): Intervention group",
"D": "Arm Label: Arm 1; Type: EXPERIMENTAL; Interventions: Behavioral: HITCM+CP | Arm Label: Arm 2; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: HITCM only | Intervention Type: BEHAVIORAL; Name: HITCM+CP; Assigned to Arm(s): Arm 1 | Intervention Type: BEHAVIORAL; Name: HITCM only; Assigned to Arm(s): Arm 2"
}
|
C
|
[
"NCT01223170",
"NCT04507529",
"NCT03959631",
"NCT00555360"
] | 27,230 |
val
|
NCT03960424
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Diabetes Management Program for Hispanic/Latino
Brief Summary: To compare Diabetes Telemonitoring to comprehensive outpatient management (COM) on critical patient-centered outcomes, including HbA1c.
|
{
"A": "Arm Label: Community Health Worker Model; Type: EXPERIMENTAL; Interventions: Behavioral: CARIÑO Project | Arm Label: Enhanced Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Enhanced Usual Care | Intervention Type: BEHAVIORAL; Name: CARIÑO Project; Assigned to Arm(s): Community Health Worker Model | Intervention Type: BEHAVIORAL; Name: Enhanced Usual Care; Assigned to Arm(s): Enhanced Usual Care",
"B": "Arm Label: Health Education (HE); Type: EXPERIMENTAL; Interventions: Behavioral: Health Education, Behavioral: Questionnaires, Drug: Nicotine Patches | Arm Label: Motivation and Problem Solving (MAPS); Type: EXPERIMENTAL; Interventions: Behavioral: Health Education, Behavioral: Questionnaires, Behavioral: Telephone Counseling Sessions, Drug: Nicotine Patches | Intervention Type: BEHAVIORAL; Name: Health Education; Assigned to Arm(s): Health Education (HE), Motivation and Problem Solving (MAPS) | Intervention Type: BEHAVIORAL; Name: Questionnaires; Assigned to Arm(s): Health Education (HE), Motivation and Problem Solving (MAPS) | Intervention Type: BEHAVIORAL; Name: Telephone Counseling Sessions; Assigned to Arm(s): Motivation and Problem Solving (MAPS) | Intervention Type: DRUG; Name: Nicotine Patches; Assigned to Arm(s): Health Education (HE), Motivation and Problem Solving (MAPS)",
"C": "Arm Label: Life Style counseling (Star-Mama); Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Life Style Counseling (Star-Mama) | Arm Label: Educational Resource Support; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Life Style Counseling (Star-Mama); Assigned to Arm(s): Life Style counseling (Star-Mama)",
"D": "Arm Label: Diabetes Telemonitoring (DTM); Type: EXPERIMENTAL; Interventions: Behavioral: Diabetes Telemonitoring | Arm Label: Comprehensive Outpatient Management (COM); Type: ACTIVE_COMPARATOR; Interventions: Other: Comprehensive Outpatient Management | Intervention Type: OTHER; Name: Comprehensive Outpatient Management; Assigned to Arm(s): Comprehensive Outpatient Management (COM) | Intervention Type: BEHAVIORAL; Name: Diabetes Telemonitoring; Assigned to Arm(s): Diabetes Telemonitoring (DTM)"
}
|
D
|
[
"NCT01152957",
"NCT01504919",
"NCT02240420",
"NCT03960424"
] | 27,231 |
val
|
NCT03960892
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Syrian REfuGees MeNTal HealTH Care Systems
Brief Summary: To implement Group Problem Management Plus (PM+) in Syrian refugees with this RCT to evaluate feasibility, acceptability, effectiveness and cost-effectiveness of the culturally adapted Group PM+ intervention for adult Syrian refugees in Turkey.
|
{
"A": "Arm Label: E-CAU with Group Problem Management Plus (PM+); Type: EXPERIMENTAL; Interventions: Behavioral: Problem Management Plus (PM+) | Arm Label: Enhanced care as usual (E-CAU) only; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Problem Management Plus (PM+); Assigned to Arm(s): E-CAU with Group Problem Management Plus (PM+)",
"B": "Arm Label: IIDEA; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Integrated Intervention for Dual Problems and Early Action | Arm Label: Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Integrated Intervention for Dual Problems and Early Action; Assigned to Arm(s): IIDEA",
"C": "Arm Label: Physical Activity Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Physical Activity Intervention | Arm Label: Wellness Control; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Wellness Control | Intervention Type: BEHAVIORAL; Name: Physical Activity Intervention; Assigned to Arm(s): Physical Activity Intervention | Intervention Type: BEHAVIORAL; Name: Wellness Control; Assigned to Arm(s): Wellness Control",
"D": "Arm Label: Behavioral intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Behavioral Intervention | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Behavioral Intervention | Intervention Type: BEHAVIORAL; Name: Behavioral Intervention; Assigned to Arm(s): Behavioral intervention, Control"
}
|
A
|
[
"NCT03960892",
"NCT02038855",
"NCT01834287",
"NCT01855282"
] | 27,232 |
val
|
NCT03960892
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Syrian REfuGees MeNTal HealTH Care Systems
Brief Summary: To implement Group Problem Management Plus (PM+) in Syrian refugees with this RCT to evaluate feasibility, acceptability, effectiveness and cost-effectiveness of the culturally adapted Group PM+ intervention for adult Syrian refugees in Turkey.
|
{
"A": "Arm Label: HSKA - Web Group; Type: EXPERIMENTAL; Interventions: Behavioral: Her Sey Kontrol Altinda (HSKA) | Arm Label: HSKA - Mobile Group; Type: EXPERIMENTAL; Interventions: Behavioral: Her Sey Kontrol Altinda (HSKA) | Arm Label: Control Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Her Sey Kontrol Altinda (HSKA); Assigned to Arm(s): HSKA - Mobile Group, HSKA - Web Group",
"B": "Arm Label: E-CAU with Group Problem Management Plus (PM+); Type: EXPERIMENTAL; Interventions: Behavioral: Problem Management Plus (PM+) | Arm Label: Enhanced care as usual (E-CAU) only; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Problem Management Plus (PM+); Assigned to Arm(s): E-CAU with Group Problem Management Plus (PM+)",
"C": "Arm Label: CBT; Type: EXPERIMENTAL; Interventions: Behavioral: CBT | Arm Label: HIV support group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: HIV support group | Intervention Type: BEHAVIORAL; Name: HIV support group; Assigned to Arm(s): HIV support group | Intervention Type: BEHAVIORAL; Name: CBT; Assigned to Arm(s): CBT",
"D": "Arm Label: HAPIFED; Type: EXPERIMENTAL; Interventions: Behavioral: HAPIFED | Arm Label: CBT-E; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: CBT-E | Intervention Type: BEHAVIORAL; Name: HAPIFED; Assigned to Arm(s): HAPIFED | Intervention Type: BEHAVIORAL; Name: CBT-E; Assigned to Arm(s): CBT-E"
}
|
B
|
[
"NCT03754829",
"NCT03960892",
"NCT00792519",
"NCT02464345"
] | 27,233 |
val
|
NCT03964454
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Individual Breastfeeding Support With Contingent Incentives for Low-Income Mothers
Brief Summary: This behavioral intervention trial will test whether a standard care breastfeeding intervention from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program plus monthly financial incentives contingent on observed breastfeeding will improve breastfeeding duration among low-income mothers compared to a standard (WIC) care control. Investigators hypothesize that the standard care plus monthly contingent financial incentives intervention will promote longer breastfeeding duration, fewer infant health issues, and greater healthcare cost savings than the standard care (control) intervention.
|
{
"A": "Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Peer-support for exclusive breastfeeding | Arm Label: No intervention; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Peer-support for exclusive breastfeeding; Assigned to Arm(s): Intervention",
"B": "Arm Label: Breastfeeding promotion intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Breastfeeding promotion intervention | Arm Label: No intervention; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Breastfeeding promotion intervention; Assigned to Arm(s): Breastfeeding promotion intervention",
"C": "Arm Label: SC + BFI; Type: EXPERIMENTAL; Interventions: Behavioral: WIC support + home-based individual support + Breastfeeding Incentives (SC+BFI) | Arm Label: SC; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: WIC support + home-based individual support (SC) | Intervention Type: BEHAVIORAL; Name: WIC support + home-based individual support + Breastfeeding Incentives (SC+BFI); Assigned to Arm(s): SC + BFI | Intervention Type: BEHAVIORAL; Name: WIC support + home-based individual support (SC); Assigned to Arm(s): SC",
"D": "Arm Label: Kilkari; Type: EXPERIMENTAL; Interventions: Other: Kilkari | Arm Label: Comparison; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Kilkari; Assigned to Arm(s): Kilkari"
}
|
C
|
[
"NCT00397150",
"NCT01352351",
"NCT03964454",
"NCT03576157"
] | 27,234 |
val
|
NCT03965767
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Does The Combined Use Of Local And Intravenous Tranexamic Acid Offer Better Surgical Field Quality During Functional Endoscopic Sinus Surgery? A Placebo-Controlled Clinical Trial
Brief Summary: Functional Endoscopic Sinus surgery (FESS) is a surgery done for chronic rhinosinusitis after failure of medical treatment. Intraoperative bleeding poses a challenge to both the surgeon and anaesthetist. Although blood loss is not massive during FESS, bleeding may obscure the surgical field prolonging the time of surgery or even leading to incompletion of the surgery.
Different methods have been used to improve the surgical field but none without side effects. The use of diathermy carries the risk of local tissue damage with the risk of subsequent bleeding. Local vasoconstrictors carry the risk of systemic absorption. Induced hypotension may not be suitable for all patients; besides, this may necessitates the use of more anaestheic drugs with their associated side effects. In addition, none of theses methods have provided ideal surgical field for the surgeon.1-3 Tranexamic acid, an antifibrinolytic agent, has been used to decrease surgical field bleeding in different surgeries showing effectiveness in its topical, oral and intravenous use.4-6 The aim of this study is to evaluate the effectiveness of local, intravenous and combined use of tranexamic acid in improving the surgical field quality during functional endoscopic sinus surgery.
|
{
"A": "Arm Label: Tranexamic Acid; Type: EXPERIMENTAL; Interventions: Drug: Tranexamic Acid | Arm Label: Normal Saline; Type: PLACEBO_COMPARATOR; Interventions: Drug: Normal Saline (placebo) | Intervention Type: DRUG; Name: Tranexamic Acid; Assigned to Arm(s): Tranexamic Acid | Intervention Type: DRUG; Name: Normal Saline (placebo); Assigned to Arm(s): Normal Saline",
"B": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Tranexamic acid | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Sodium Chloride 0.9% | Intervention Type: DRUG; Name: Tranexamic acid; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Sodium Chloride 0.9%; Assigned to Arm(s): 2",
"C": "Arm Label: control; Type: PLACEBO_COMPARATOR; Interventions: Drug: Tranexamic Acid | Arm Label: local group; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tranexamic Acid | Arm Label: systemic group; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tranexamic Acid | Arm Label: combined local and systemic; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tranexamic Acid | Intervention Type: DRUG; Name: Tranexamic Acid; Assigned to Arm(s): combined local and systemic, control, local group, systemic group",
"D": "Arm Label: Total Intravenous; Type: EXPERIMENTAL; Interventions: Drug: Propofol | Arm Label: Inhaled Anesthetic; Type: ACTIVE_COMPARATOR; Interventions: Drug: Sevoflurane | Intervention Type: DRUG; Name: Propofol; Assigned to Arm(s): Total Intravenous | Intervention Type: DRUG; Name: Sevoflurane; Assigned to Arm(s): Inhaled Anesthetic"
}
|
C
|
[
"NCT01111669",
"NCT00375258",
"NCT03965767",
"NCT02578862"
] | 27,235 |
val
|
NCT03965871
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multicentre, Double-blind, Randomised, Placebo - Controlled Phase II Study to Assess Efficacy, Safety and Pharmacokinetics of Inhaled Esketamine in Subject With Treatment-resistant Bipolar Depression
Brief Summary: The purpose of the study is to determine the efficacy, safety and pharmacokinetics of inhaled Esketamine in participants with treatment-resistant bipolar depression (TRBD). The study is to determine the efficacy and dose response of three Esketamine doses, compared with placebo.
|
{
"A": "Arm Label: AZD6765 (150 mg) / Placebo; Type: EXPERIMENTAL; Interventions: Drug: AZD6765 | Arm Label: Placebo / AZD6765 (150 mg); Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo to AZD6765 | Intervention Type: DRUG; Name: AZD6765; Assigned to Arm(s): AZD6765 (150 mg) / Placebo | Intervention Type: DRUG; Name: Placebo to AZD6765; Assigned to Arm(s): Placebo / AZD6765 (150 mg)",
"B": "Arm Label: Aspirin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Aspirin | Arm Label: N-acetyl-cysteine; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: N-acetyl-cysteine (NAC) | Arm Label: Aspirin and NAC; Type: ACTIVE_COMPARATOR; Interventions: Drug: Aspirin, Dietary Supplement: N-acetyl-cysteine (NAC) | Arm Label: Sugar Pill; Type: PLACEBO_COMPARATOR; Interventions: Drug: Sugar Pill | Intervention Type: DRUG; Name: Aspirin; Assigned to Arm(s): Aspirin, Aspirin and NAC | Intervention Type: DIETARY_SUPPLEMENT; Name: N-acetyl-cysteine (NAC); Assigned to Arm(s): Aspirin and NAC, N-acetyl-cysteine | Intervention Type: DRUG; Name: Sugar Pill; Assigned to Arm(s): Sugar Pill",
"C": "Arm Label: Esketamine low dose; Type: EXPERIMENTAL; Interventions: Drug: Esketamine DPI - low dose | Arm Label: Esketamine medium dose; Type: EXPERIMENTAL; Interventions: Drug: Esketamine DPI - medium dose | Arm Label: Esketamine high dose; Type: EXPERIMENTAL; Interventions: Drug: Esketamine DPI - high dose | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo DPI | Intervention Type: DRUG; Name: Esketamine DPI - low dose; Assigned to Arm(s): Esketamine low dose | Intervention Type: DRUG; Name: Esketamine DPI - medium dose; Assigned to Arm(s): Esketamine medium dose | Intervention Type: DRUG; Name: Esketamine DPI - high dose; Assigned to Arm(s): Esketamine high dose | Intervention Type: DRUG; Name: Placebo DPI; Assigned to Arm(s): Placebo",
"D": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: AZD6765 | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: AZD6765 | Arm Label: 3; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: AZD6765; Assigned to Arm(s): 1, 2 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 3"
}
|
C
|
[
"NCT00986479",
"NCT01797575",
"NCT03965871",
"NCT00781742"
] | 27,236 |
val
|
NCT03965871
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multicentre, Double-blind, Randomised, Placebo - Controlled Phase II Study to Assess Efficacy, Safety and Pharmacokinetics of Inhaled Esketamine in Subject With Treatment-resistant Bipolar Depression
Brief Summary: The purpose of the study is to determine the efficacy, safety and pharmacokinetics of inhaled Esketamine in participants with treatment-resistant bipolar depression (TRBD). The study is to determine the efficacy and dose response of three Esketamine doses, compared with placebo.
|
{
"A": "Arm Label: Intranasal Esketamine 84mg plus Oral Antidepressant; Type: EXPERIMENTAL; Interventions: Drug: Esketamine, Drug: Duloxetine (Oral Antidepressant), Drug: Escitalopram (Oral antidepressant), Drug: Sertraline (Oral Antidepressant), Drug: Venlafaxine Extended Release (XR) (Oral Antidepressant) | Arm Label: Esketamine 56 mg plus Oral Antidepressant; Type: EXPERIMENTAL; Interventions: Drug: Esketamine, Drug: Duloxetine (Oral Antidepressant), Drug: Escitalopram (Oral antidepressant), Drug: Sertraline (Oral Antidepressant), Drug: Venlafaxine Extended Release (XR) (Oral Antidepressant) | Arm Label: Placebo plus Oral Antidepressant; Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo, Drug: Duloxetine (Oral Antidepressant), Drug: Escitalopram (Oral antidepressant), Drug: Sertraline (Oral Antidepressant), Drug: Venlafaxine Extended Release (XR) (Oral Antidepressant) | Intervention Type: DRUG; Name: Esketamine; Assigned to Arm(s): Esketamine 56 mg plus Oral Antidepressant, Intranasal Esketamine 84mg plus Oral Antidepressant | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo plus Oral Antidepressant | Intervention Type: DRUG; Name: Duloxetine (Oral Antidepressant); Assigned to Arm(s): Esketamine 56 mg plus Oral Antidepressant, Intranasal Esketamine 84mg plus Oral Antidepressant, Placebo plus Oral Antidepressant | Intervention Type: DRUG; Name: Escitalopram (Oral antidepressant); Assigned to Arm(s): Esketamine 56 mg plus Oral Antidepressant, Intranasal Esketamine 84mg plus Oral Antidepressant, Placebo plus Oral Antidepressant | Intervention Type: DRUG; Name: Sertraline (Oral Antidepressant); Assigned to Arm(s): Esketamine 56 mg plus Oral Antidepressant, Intranasal Esketamine 84mg plus Oral Antidepressant, Placebo plus Oral Antidepressant | Intervention Type: DRUG; Name: Venlafaxine Extended Release (XR) (Oral Antidepressant); Assigned to Arm(s): Esketamine 56 mg plus Oral Antidepressant, Intranasal Esketamine 84mg plus Oral Antidepressant, Placebo plus Oral Antidepressant",
"B": "Arm Label: Esketamine low dose; Type: EXPERIMENTAL; Interventions: Drug: Esketamine DPI - low dose | Arm Label: Esketamine medium dose; Type: EXPERIMENTAL; Interventions: Drug: Esketamine DPI - medium dose | Arm Label: Esketamine high dose; Type: EXPERIMENTAL; Interventions: Drug: Esketamine DPI - high dose | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo DPI | Intervention Type: DRUG; Name: Esketamine DPI - low dose; Assigned to Arm(s): Esketamine low dose | Intervention Type: DRUG; Name: Esketamine DPI - medium dose; Assigned to Arm(s): Esketamine medium dose | Intervention Type: DRUG; Name: Esketamine DPI - high dose; Assigned to Arm(s): Esketamine high dose | Intervention Type: DRUG; Name: Placebo DPI; Assigned to Arm(s): Placebo",
"C": "Arm Label: Ketamine, Then Placebo; Type: EXPERIMENTAL; Interventions: Drug: Ketamine, Drug: Placebo | Arm Label: Placebo, Then Ketamine; Type: EXPERIMENTAL; Interventions: Drug: Ketamine, Drug: Placebo | Intervention Type: DRUG; Name: Ketamine; Assigned to Arm(s): Ketamine, Then Placebo, Placebo, Then Ketamine | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Ketamine, Then Placebo, Placebo, Then Ketamine",
"D": "Arm Label: Ketamine; Type: EXPERIMENTAL; Interventions: Drug: Ketamine | Arm Label: Propofol; Type: ACTIVE_COMPARATOR; Interventions: Drug: Propofol | Intervention Type: DRUG; Name: Ketamine; Assigned to Arm(s): Ketamine | Intervention Type: DRUG; Name: Propofol; Assigned to Arm(s): Propofol"
}
|
B
|
[
"NCT02417064",
"NCT03965871",
"NCT00088699",
"NCT01306760"
] | 27,237 |
val
|
NCT03966716
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: HipSTHeR - a Registerbased Randomized Controlled Trial - Hip Screws or (Total) Hip Replacement for Undisplaced Femoral Neck Fractures in Elderly Patients.
Brief Summary: A registerbased RCT will investigate whether arthroplasty can decrease the reoperation rate compared to internal fixation for patients with an undisplaced femoral neck fracture (Garden I-II).
|
{
"A": "Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Device: Total hip arthroplasty | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Device: Hemi-arthroplasty | Intervention Type: DEVICE; Name: Total hip arthroplasty; Assigned to Arm(s): 1 | Intervention Type: DEVICE; Name: Hemi-arthroplasty; Assigned to Arm(s): 2",
"B": "Arm Label: Control group; Type: ACTIVE_COMPARATOR; Interventions: Device: Cemented hemiarthroplasty | Arm Label: Treatment group; Type: ACTIVE_COMPARATOR; Interventions: Device: Cemented total hip arthroplasty | Intervention Type: DEVICE; Name: Cemented total hip arthroplasty; Assigned to Arm(s): Treatment group | Intervention Type: DEVICE; Name: Cemented hemiarthroplasty; Assigned to Arm(s): Control group",
"C": "Arm Label: Cemented femoral stem; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Cemented femoral stem | Arm Label: Uncemented femoral stem; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Uncemented femoral stem | Intervention Type: PROCEDURE; Name: Uncemented femoral stem; Assigned to Arm(s): Uncemented femoral stem | Intervention Type: PROCEDURE; Name: Cemented femoral stem; Assigned to Arm(s): Cemented femoral stem",
"D": "Arm Label: Arthroplasty; Type: EXPERIMENTAL; Interventions: Device: Arthroplasty | Arm Label: Internal Fixation; Type: ACTIVE_COMPARATOR; Interventions: Device: Internal Fixation | Intervention Type: DEVICE; Name: Arthroplasty; Assigned to Arm(s): Arthroplasty | Intervention Type: DEVICE; Name: Internal Fixation; Assigned to Arm(s): Internal Fixation"
}
|
D
|
[
"NCT00556842",
"NCT02246335",
"NCT02247791",
"NCT03966716"
] | 27,238 |
val
|
NCT03966885
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Zambia Common Elements Treatment Approach Pilot Study
Brief Summary: This is a randomized controlled trial (RCT) evaluating the effectiveness of an alcohol brief intervention alone compared to the brief intervention plus an evidence-based psychotherapy (CETA) in reducing alcohol misuse and co-occurring mental health problems among persons with HIV in Zambia.
|
{
"A": "Arm Label: Brief Intervention (BI); Type: EXPERIMENTAL; Interventions: Behavioral: Brief Intervention | Arm Label: Brief Intervention + CETA; Type: EXPERIMENTAL; Interventions: Behavioral: Brief Intervention, Behavioral: Common Elements Treatment Approach (CETA) | Intervention Type: BEHAVIORAL; Name: Brief Intervention; Assigned to Arm(s): Brief Intervention (BI), Brief Intervention + CETA | Intervention Type: BEHAVIORAL; Name: Common Elements Treatment Approach (CETA); Assigned to Arm(s): Brief Intervention + CETA",
"B": "Arm Label: PLH-YC; Type: EXPERIMENTAL; Interventions: Behavioral: PLH-YC | Arm Label: Lecture; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Lecture | Intervention Type: BEHAVIORAL; Name: PLH-YC; Assigned to Arm(s): PLH-YC | Intervention Type: BEHAVIORAL; Name: Lecture; Assigned to Arm(s): Lecture",
"C": "Arm Label: Intervention (iMBC/ECD + C-PrES); Type: EXPERIMENTAL; Interventions: Behavioral: Integrated Mothers and Babies Course | Arm Label: Control (C-PrES); Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Integrated Mothers and Babies Course; Assigned to Arm(s): Intervention (iMBC/ECD + C-PrES)",
"D": "Arm Label: Collaborative Stepped Care; Type: EXPERIMENTAL; Interventions: Other: Collaborative Stepped Care Intervention | Arm Label: Enhanced Usual Care; Type: ACTIVE_COMPARATOR; Interventions: Other: Enhanced Usual Care | Intervention Type: OTHER; Name: Collaborative Stepped Care Intervention; Assigned to Arm(s): Collaborative Stepped Care | Intervention Type: OTHER; Name: Enhanced Usual Care; Assigned to Arm(s): Enhanced Usual Care"
}
|
A
|
[
"NCT03966885",
"NCT04721730",
"NCT03665246",
"NCT00446407"
] | 27,239 |
val
|
NCT03966885
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Zambia Common Elements Treatment Approach Pilot Study
Brief Summary: This is a randomized controlled trial (RCT) evaluating the effectiveness of an alcohol brief intervention alone compared to the brief intervention plus an evidence-based psychotherapy (CETA) in reducing alcohol misuse and co-occurring mental health problems among persons with HIV in Zambia.
|
{
"A": "Arm Label: Brief Intervention (BI); Type: EXPERIMENTAL; Interventions: Behavioral: Brief Intervention | Arm Label: Brief Intervention + CETA; Type: EXPERIMENTAL; Interventions: Behavioral: Brief Intervention, Behavioral: Common Elements Treatment Approach (CETA) | Intervention Type: BEHAVIORAL; Name: Brief Intervention; Assigned to Arm(s): Brief Intervention (BI), Brief Intervention + CETA | Intervention Type: BEHAVIORAL; Name: Common Elements Treatment Approach (CETA); Assigned to Arm(s): Brief Intervention + CETA",
"B": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Behavioral: Brief Counseling Intervention (BCI) | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: Naltrexone | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Other: BCI + Naltrexone | Arm Label: 4; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Treatment as Usual | Intervention Type: BEHAVIORAL; Name: Brief Counseling Intervention (BCI); Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Naltrexone; Assigned to Arm(s): 2 | Intervention Type: OTHER; Name: BCI + Naltrexone; Assigned to Arm(s): 3 | Intervention Type: BEHAVIORAL; Name: Treatment as Usual; Assigned to Arm(s): 4",
"C": "Arm Label: CETA; Type: EXPERIMENTAL; Interventions: Behavioral: CETA | Arm Label: Treatment as usual; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Treatment as usual | Intervention Type: BEHAVIORAL; Name: CETA; Assigned to Arm(s): CETA | Intervention Type: BEHAVIORAL; Name: Treatment as usual; Assigned to Arm(s): Treatment as usual",
"D": "Arm Label: Brief Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Brief Intervention | Arm Label: MET+CBT Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Motivational Enhancement Therapy (MET) Intervention, Behavioral: Cognitive Behavioral Therapy (CBT) Intervention | Arm Label: Assessment-Only Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Brief Intervention; Assigned to Arm(s): Brief Intervention | Intervention Type: BEHAVIORAL; Name: Motivational Enhancement Therapy (MET) Intervention; Assigned to Arm(s): MET+CBT Intervention | Intervention Type: BEHAVIORAL; Name: Cognitive Behavioral Therapy (CBT) Intervention; Assigned to Arm(s): MET+CBT Intervention"
}
|
A
|
[
"NCT03966885",
"NCT00675961",
"NCT02790827",
"NCT02720237"
] | 27,240 |
val
|
NCT03966963
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Systematic Case Series Study Investigating the Effectiveness of Eye Movement Desensitization Reprocessing (EMDR) in the Treatment of Childhood Sexual Abuse in Adolescents and Adult Survivors
Brief Summary: This study investigates the effectiveness of EMDR for survivors of childhood sexual abuse. All participants will undertake a standard course of EMDR via the National Heath Service program, alongside a number of questionnaires and a follow-up interview.
|
{
"A": "Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Cognitive Processing Therapy | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive Processing Therapy, Behavioral: Hypnosis | Intervention Type: BEHAVIORAL; Name: Cognitive Processing Therapy; Assigned to Arm(s): 1, 2 | Intervention Type: BEHAVIORAL; Name: Hypnosis; Assigned to Arm(s): 2",
"B": "Arm Label: CBT for PTSD; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Cognitive Behavioral Therapy for PTSD | Arm Label: Imagery Rehearsal Therapy + CBT for PTSD; Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive Behavioral Therapy for PTSD, Behavioral: Imagery Rehearsal Therapy | Intervention Type: BEHAVIORAL; Name: Cognitive Behavioral Therapy for PTSD; Assigned to Arm(s): CBT for PTSD, Imagery Rehearsal Therapy + CBT for PTSD | Intervention Type: BEHAVIORAL; Name: Imagery Rehearsal Therapy; Assigned to Arm(s): Imagery Rehearsal Therapy + CBT for PTSD",
"C": "Arm Label: Eye Movement Desensitization Reprocessing (EMDR); Type: EXPERIMENTAL; Interventions: Behavioral: Eye Movement Desensitization Reprocessing (EMDR) | Intervention Type: BEHAVIORAL; Name: Eye Movement Desensitization Reprocessing (EMDR); Assigned to Arm(s): Eye Movement Desensitization Reprocessing (EMDR)",
"D": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Other: TF-CBT | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Other: Treatment as Usual (TAU) | Intervention Type: OTHER; Name: TF-CBT; Assigned to Arm(s): 1 | Intervention Type: OTHER; Name: Treatment as Usual (TAU); Assigned to Arm(s): 2"
}
|
C
|
[
"NCT00725192",
"NCT03169712",
"NCT03966963",
"NCT00635752"
] | 27,241 |
val
|
NCT03966963
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Systematic Case Series Study Investigating the Effectiveness of Eye Movement Desensitization Reprocessing (EMDR) in the Treatment of Childhood Sexual Abuse in Adolescents and Adult Survivors
Brief Summary: This study investigates the effectiveness of EMDR for survivors of childhood sexual abuse. All participants will undertake a standard course of EMDR via the National Heath Service program, alongside a number of questionnaires and a follow-up interview.
|
{
"A": "Arm Label: Trauma Center Trauma-Sensitive Yoga (TCTSY); Type: EXPERIMENTAL; Interventions: Behavioral: Trauma Center Trauma Sensitive Yoga Intervention (TCTSY) | Arm Label: Cognitive Processing Therapy (CPT); Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Cognitive Processing Therapy | Intervention Type: BEHAVIORAL; Name: Trauma Center Trauma Sensitive Yoga Intervention (TCTSY); Assigned to Arm(s): Trauma Center Trauma-Sensitive Yoga (TCTSY) | Intervention Type: BEHAVIORAL; Name: Cognitive Processing Therapy; Assigned to Arm(s): Cognitive Processing Therapy (CPT)",
"B": "Arm Label: 1; Type: EXPERIMENTAL; Interventions: Other: Cognitive Behavioral Treatment for Insomnia (CBT-I) | Arm Label: 2; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Cognitive Behavioral Treatment for Insomnia (CBT-I); Assigned to Arm(s): 1",
"C": "Arm Label: Eye Movement Desensitization Reprocessing (EMDR); Type: EXPERIMENTAL; Interventions: Behavioral: Eye Movement Desensitization Reprocessing (EMDR) | Intervention Type: BEHAVIORAL; Name: Eye Movement Desensitization Reprocessing (EMDR); Assigned to Arm(s): Eye Movement Desensitization Reprocessing (EMDR)",
"D": "Arm Label: Control - VSLA; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Control - Mental Health; Type: OTHER; Interventions: Behavioral: Treatment as usual | Arm Label: Voluntary Savings/Loans Assoc; Type: EXPERIMENTAL; Interventions: Behavioral: Voluntary Savings/Loans Assoc | Arm Label: Cognitive Processing Therapy; Type: EXPERIMENTAL; Interventions: Behavioral: Cognitive Processing Therapy | Intervention Type: BEHAVIORAL; Name: Treatment as usual; Assigned to Arm(s): Control - Mental Health | Intervention Type: BEHAVIORAL; Name: Voluntary Savings/Loans Assoc; Assigned to Arm(s): Voluntary Savings/Loans Assoc | Intervention Type: BEHAVIORAL; Name: Cognitive Processing Therapy; Assigned to Arm(s): Cognitive Processing Therapy"
}
|
C
|
[
"NCT02640690",
"NCT00881647",
"NCT03966963",
"NCT01385163"
] | 27,242 |
val
|
NCT03968432
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Feasibility, Acceptability, and Preliminary Effectiveness of Parent Targeted Interventions in Vaccination Pain Management of Infants: A Pilot Randomized Control Trial (RCT)
Brief Summary: The overall aim of this study is to investigate the feasibility, acceptability, preliminary effectiveness and sustainability of parent-targeted interventions for pain management during vaccination of infants. To achieve the goal, a two-phase pilot randomized control trial is planned. Study one, currently in the data collection phase, aims i) to evaluate the feasibility and acceptability of data collection tools, participants' recruitment procedures and implementation process of parent-targeted interventions prior to infant vaccination at two, four, or six months. ii) to evaluate the preliminary effectiveness of parent-targeted interventions prior to infant vaccination in promoting the use of pain management strategies during vaccinations of infants at two, four, or six months. iii) to identify the parent's knowledge, use, intention and recommendation to use the recommended pain management strategies, and facilitators and barriers influencing the implementation of the parent-targeted interventions during vaccinations of infants at two, four, or six months. Methods. This study is a prospective multi-faceted two-armed pilot randomized control trial (RCT). a pilot randomized control trial. The participants are parents of infants, recruited before the infants receive their 2, 4, or 6- month vaccinations, who responded to the online invitation and consent to participate in this study. Parents living in Canada and prior to the infant receiving one of the three vaccinations were invited to participate through an online recruitment process. A sample of 50 parent/infant dyads in each group of control and intervention is estimated to be sufficient to achieve the study's goals. The outcome measurements are being done by five brief study questionnaires; Brief information of the study goals and the researchers' affiliation followed by a hyperlink to the survey were posted on different online platforms. Eligible parents of infants who respond to the study invitation are being randomly allocated to 1 of 2 groups (Intervention and control). There are two interventions in the study one being compared: 1) Be Sweet to Babies Videos and Pamphlet; and 2) Be Sweet to Babies Videos, pamphlet, and MIAS\&Q. After the intervention, the impact of the vaccination pain management video and brochure followed by MIAS\&Q questions are being evaluated by a brief online survey exploring the use of pain management (breastfeeding or sucrose and upright secure holding) during infants' vaccination in both groups. Following that, the opinion of parents about the understandability, applicability, feasibility, and acceptability of this study are evaluated. All data are being collected electronically using REDCap survey tool. SPSS version 23.0 (SPSS Inc, Chicago, Illinois) will be used to perform all descriptive and inferential statistical analyses. NVivo version 11.0 (Qualitative data analysis Software; QSR International Pty Ltd) will be used for content analysis and descriptive statistical analysis and thematic analysis will be used for the analysis of the qualitative data.
|
{
"A": "Arm Label: The Lullaby Group; Type: EXPERIMENTAL; Interventions: Behavioral: The Lullaby Group | Arm Label: Control Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: The Lullaby Group; Assigned to Arm(s): The Lullaby Group",
"B": "Arm Label: A; Type: OTHER; Interventions: Other: aromatherapy massage | Arm Label: B; Type: OTHER; Interventions: Other: aromatherapy massage | Arm Label: C; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: aromatherapy massage; Assigned to Arm(s): A, B",
"C": "Arm Label: Standard Care; Type: SHAM_COMPARATOR; Interventions: Behavioral: Be Sweet to Babies Videos and Pamphlet | Arm Label: Intervention; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: MIAS&Q, Behavioral: Be Sweet to Babies Videos and Pamphlet | Intervention Type: BEHAVIORAL; Name: MIAS&Q; Assigned to Arm(s): Intervention | Intervention Type: BEHAVIORAL; Name: Be Sweet to Babies Videos and Pamphlet; Assigned to Arm(s): Intervention, Standard Care",
"D": "Arm Label: 0.1ml 24% sucrose concurrent opioids; Type: ACTIVE_COMPARATOR; Interventions: Other: sucrose | Arm Label: 0.5ml 24% sucrose concurrent opioids; Type: ACTIVE_COMPARATOR; Interventions: Other: sucrose | Arm Label: 1.0ml 24% sucrose concurrent opioids; Type: ACTIVE_COMPARATOR; Interventions: Other: sucrose | Arm Label: 0.1ml 24% sucrose no opioids; Type: ACTIVE_COMPARATOR; Interventions: Other: sucrose | Arm Label: 0.5ml 24% sucrose no opioids; Type: ACTIVE_COMPARATOR; Interventions: Other: sucrose | Arm Label: 1.0ml 24% sucrose no opioids; Type: ACTIVE_COMPARATOR; Interventions: Other: sucrose | Intervention Type: OTHER; Name: sucrose; Assigned to Arm(s): 0.1ml 24% sucrose concurrent opioids, 0.1ml 24% sucrose no opioids, 0.5ml 24% sucrose concurrent opioids, 0.5ml 24% sucrose no opioids, 1.0ml 24% sucrose concurrent opioids, 1.0ml 24% sucrose no opioids"
}
|
C
|
[
"NCT04692584",
"NCT00624637",
"NCT03968432",
"NCT02134873"
] | 27,243 |
val
|
NCT03972293
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: 2018 Intern Health Study Micro-randomized Trial: Developing a Mobile Health App to Improve Mental Health and Maintain Healthy Behaviors During the Internship Year
Brief Summary: The aim of this trial is to evaluate the efficacy of an intervention (delivered through a smartphone) for improving the mood, physical activity, and sleep of medical interns.
|
{
"A": "Arm Label: Mobile Video Counseling; Type: EXPERIMENTAL; Interventions: Behavioral: Stress management counseling | Arm Label: Offline Counseling; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Stress management counseling | Arm Label: Selfcare; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Stress management counseling; Assigned to Arm(s): Mobile Video Counseling, Offline Counseling",
"B": "Arm Label: Transcendental Meditation Intervention Arm; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Transcendental Meditation | Arm Label: Treatment as usual(TAU) Control Arm; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Transcendental Meditation; Assigned to Arm(s): Transcendental Meditation Intervention Arm",
"C": "Arm Label: Within-participant Micro-randomization; Type: EXPERIMENTAL; Interventions: Behavioral: Intern Health Study behavioral change mobile notification, Behavioral: Intern Health Study mobile app | Arm Label: No intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Intern Health Study mobile app | Intervention Type: BEHAVIORAL; Name: Intern Health Study behavioral change mobile notification; Assigned to Arm(s): Within-participant Micro-randomization | Intervention Type: BEHAVIORAL; Name: Intern Health Study mobile app; Assigned to Arm(s): No intervention, Within-participant Micro-randomization",
"D": "Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Corporate Athlete Resilience (CAR) Training Program | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Corporate Athlete Resilience (CAR) Training Program; Assigned to Arm(s): Intervention"
}
|
C
|
[
"NCT03256682",
"NCT04632368",
"NCT03972293",
"NCT03645512"
] | 27,244 |
val
|
NCT03973424
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Mobile Methods for Reducing Obesity Risk in Parents and Children: A Randomized Trial
Brief Summary: The purpose of this study is to test the efficacy of an innovative 6-month smartphone-delivered intervention using simplified monitoring of dietary intake compared to a smartphone-delivered intervention with standard calorie monitoring among parents with overweight or obesity.
|
{
"A": "Arm Label: Simple; Type: EXPERIMENTAL; Interventions: Behavioral: Simple | Arm Label: Standard; Type: EXPERIMENTAL; Interventions: Behavioral: Standard | Intervention Type: BEHAVIORAL; Name: Simple; Assigned to Arm(s): Simple | Intervention Type: BEHAVIORAL; Name: Standard; Assigned to Arm(s): Standard",
"B": "Arm Label: RIDE; Type: EXPERIMENTAL; Interventions: Behavioral: RIDE e-health application | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: RIDE e-health application; Assigned to Arm(s): RIDE",
"C": "Arm Label: Mobile Technology Plus (MT+); Type: EXPERIMENTAL; Interventions: Behavioral: Mobile Technology Plus | Arm Label: Mobile Technology (MT); Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Mobile Technology | Intervention Type: BEHAVIORAL; Name: Mobile Technology Plus; Assigned to Arm(s): Mobile Technology Plus (MT+) | Intervention Type: BEHAVIORAL; Name: Mobile Technology; Assigned to Arm(s): Mobile Technology (MT)",
"D": "Arm Label: Standard; Type: EXPERIMENTAL; Interventions: Behavioral: Standard | Arm Label: Technology Supported condition; Type: EXPERIMENTAL; Interventions: Behavioral: Technology Supported | Arm Label: Self-Guided; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Technology Supported; Assigned to Arm(s): Technology Supported condition | Intervention Type: BEHAVIORAL; Name: Standard; Assigned to Arm(s): Standard"
}
|
A
|
[
"NCT03973424",
"NCT00883350",
"NCT03329079",
"NCT01051713"
] | 27,245 |
val
|
NCT03973931
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (The Nudge Study)
Brief Summary: The study plans to learn if sending different text messages, serving as reminders or encouragement, may help patients take their medication more often if they have had trouble keeping up with their medicines.
|
{
"A": "Arm Label: Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Generic Nudge; Type: EXPERIMENTAL; Interventions: Behavioral: Nudge | Arm Label: Optimized nudge; Type: EXPERIMENTAL; Interventions: Behavioral: Nudge | Arm Label: Optimized nudge plus AI Chat Bot; Type: EXPERIMENTAL; Interventions: Behavioral: Nudge | Intervention Type: BEHAVIORAL; Name: Nudge; Assigned to Arm(s): Generic Nudge, Optimized nudge, Optimized nudge plus AI Chat Bot",
"B": "Arm Label: SINEMA intervention group; Type: EXPERIMENTAL; Interventions: Behavioral: SINEMA intervention | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: SINEMA intervention; Assigned to Arm(s): SINEMA intervention group",
"C": "Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: SMS reminders of medicines intake | Intervention Type: BEHAVIORAL; Name: SMS reminders of medicines intake; Assigned to Arm(s): Intervention",
"D": "Arm Label: self-care promotion; Type: EXPERIMENTAL; Interventions: Other: Multifaceted strategy based on sending text messages(SMS) | Arm Label: Control group; Type: ACTIVE_COMPARATOR; Interventions: Other: Usual outpatient care | Intervention Type: OTHER; Name: Multifaceted strategy based on sending text messages(SMS); Assigned to Arm(s): self-care promotion | Intervention Type: OTHER; Name: Usual outpatient care; Assigned to Arm(s): Control group"
}
|
A
|
[
"NCT03973931",
"NCT03185858",
"NCT03105687",
"NCT04062461"
] | 27,246 |
val
|
NCT03973931
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Personalized Patient Data and Behavioral Nudges to Improve Adherence to Chronic Cardiovascular Medications (The Nudge Study)
Brief Summary: The study plans to learn if sending different text messages, serving as reminders or encouragement, may help patients take their medication more often if they have had trouble keeping up with their medicines.
|
{
"A": "Arm Label: Intervention group; Type: EXPERIMENTAL; Interventions: Device: \"COMBINED STRATEGY\" | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: \"COMBINED STRATEGY\"; Assigned to Arm(s): Intervention group",
"B": "Arm Label: Weekly SMS, brief message; Type: EXPERIMENTAL; Interventions: Behavioral: Short Message Services to Support ARV therapy adherence | Arm Label: Control Group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Short Message Services to Support ARV therapy adherence | Arm Label: Daily SMS, Brief message; Type: EXPERIMENTAL; Interventions: Behavioral: Short Message Services to Support ARV therapy adherence | Arm Label: Daily SMS, Long Message; Type: EXPERIMENTAL; Interventions: Behavioral: Short Message Services to Support ARV therapy adherence | Arm Label: Weekly SMS, Long Message; Type: EXPERIMENTAL; Interventions: Behavioral: Short Message Services to Support ARV therapy adherence | Intervention Type: BEHAVIORAL; Name: Short Message Services to Support ARV therapy adherence; Assigned to Arm(s): Control Group, Daily SMS, Brief message, Daily SMS, Long Message, Weekly SMS, Long Message, Weekly SMS, brief message",
"C": "Arm Label: Intensive BP control; Type: EXPERIMENTAL; Interventions: Drug: Intensive BP control | Arm Label: Standard BP control; Type: ACTIVE_COMPARATOR; Interventions: Drug: Standard BP control | Intervention Type: DRUG; Name: Intensive BP control; Assigned to Arm(s): Intensive BP control | Intervention Type: DRUG; Name: Standard BP control; Assigned to Arm(s): Standard BP control",
"D": "Arm Label: Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Generic Nudge; Type: EXPERIMENTAL; Interventions: Behavioral: Nudge | Arm Label: Optimized nudge; Type: EXPERIMENTAL; Interventions: Behavioral: Nudge | Arm Label: Optimized nudge plus AI Chat Bot; Type: EXPERIMENTAL; Interventions: Behavioral: Nudge | Intervention Type: BEHAVIORAL; Name: Nudge; Assigned to Arm(s): Generic Nudge, Optimized nudge, Optimized nudge plus AI Chat Bot"
}
|
D
|
[
"NCT02314663",
"NCT01058694",
"NCT03015311",
"NCT03973931"
] | 27,247 |
val
|
NCT03975335
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: An Intervention Program to Reduce NCD Related Behavioral Risk Factor Among Adolescents in Institutional Settings of Bangladesh
Brief Summary: This is a before-after designed intervention study conducted in two randomly selected secondary schools- one was selected randomly as intervention school and the another as control school. A baseline survey was conducted among the students of both schools by a pre-tested questionnaire to attain their current status of knowledge, attitude and practices related to NCDs. Afterward, students were enrolled in the intervention group who met the eligibility criteria from the intervention school. The intervention was given through a health promotion session to a group of students, not more than 25 at a time, by trained facilitators. A post-intervention end line survey was conducted among all the participants from both schools using the same questionnaire three months after the baseline survey. An intervention has been developed based on some principals of two psychosocial theory- Motivational Interview and Social Cognitive Theory. Emphasis was given on motivating the adolescents towards a healthy lifestyle, supporting self-efficacy to be changed, guiding self-regulatory ways along with facilitating desired changing process by empowering them with choices about the preventive measures of NCDs. This intervention is expected to increase awareness by equipping the adolescents with specific knowledge and skills and thus, facilitate an eventual change in their practiced risk behaviors.
|
{
"A": "Arm Label: Behaviour; Type: EXPERIMENTAL; Interventions: Behavioral: Health Education and Physical activity program | Arm Label: Nutrition; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Health Education and Physical activity program, Dietary Supplement: Nutrition Program | Intervention Type: BEHAVIORAL; Name: Health Education and Physical activity program; Assigned to Arm(s): Behaviour, Nutrition | Intervention Type: DIETARY_SUPPLEMENT; Name: Nutrition Program; Assigned to Arm(s): Nutrition",
"B": "Arm Label: Physical activity; Type: EXPERIMENTAL; Interventions: Behavioral: Physical activity | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Physical activity; Assigned to Arm(s): Physical activity",
"C": "Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Short Intervention; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Short-term educational program | Arm Label: Long Intervention; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Long-term educational program | Intervention Type: BEHAVIORAL; Name: Long-term educational program; Assigned to Arm(s): Long Intervention | Intervention Type: BEHAVIORAL; Name: Short-term educational program; Assigned to Arm(s): Short Intervention",
"D": "Arm Label: Intervention group; Type: EXPERIMENTAL; Interventions: Behavioral: Health education | Arm Label: Control group; Type: PLACEBO_COMPARATOR; Interventions: Other: Carrier Guidance | Intervention Type: BEHAVIORAL; Name: Health education; Assigned to Arm(s): Intervention group | Intervention Type: OTHER; Name: Carrier Guidance; Assigned to Arm(s): Control group"
}
|
D
|
[
"NCT03768245",
"NCT02132494",
"NCT03504059",
"NCT03975335"
] | 27,248 |
val
|
NCT03975530
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Piloting a Precision Approach to Home Visiting
Brief Summary: The proposed study will be a randomized pilot study. Family Spirit home-visiting sites from the Inter-Tribal Council of Michigan (ITC of MI) will be selected based on comparability and randomized to provide either standard Family Spirit or precision Family Spirit to their clients. Sites in both groups will use an electronic platform to support implementation. The investigators will select four sites and randomize two of them to standard Family Spirit and two to precision Family Spirit. Sites will be matched based on annual volume of clients served and geographic similarity (i.e. urban vs. rural). All participating sites will be trained in the electronic implementation support platform. The two sites randomized to provide the precision approach will receive additional training on how to provide it.
In each site, all new clients who are prenatal or up to 2-months postpartum will be offered participation in the study. The study will then follow them until 12 months postpartum and measure outcomes during this time (see measurement table below). Qualitative interviews with precision participants will be done at 6 and 12 months postpartum. Focus group discussions with home visitors will also be completed during regular study team meetings. Analysis of study instruments (basic psychometrics based on baseline and end line data) and preliminary differences between the sites on Aim 3 and 4 outcomes will be done in December 2019 assuming the investigators have achieved their estimated sample size with enough retention for 6-months post enrollment. Dissemination of results will be done upon completion of the analysis.
|
{
"A": "Arm Label: Precision Family Spirit; Type: EXPERIMENTAL; Interventions: Behavioral: Precision Family Spirit | Arm Label: Standard Family Spirit; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Standard Family Spirit | Intervention Type: BEHAVIORAL; Name: Precision Family Spirit; Assigned to Arm(s): Precision Family Spirit | Intervention Type: BEHAVIORAL; Name: Standard Family Spirit; Assigned to Arm(s): Standard Family Spirit",
"B": "Arm Label: COHS administered fluoride varnish and oral health education; Type: EXPERIMENTAL; Interventions: Device: Fluoride varnish, Behavioral: Oral health education | Arm Label: Usual care; Type: ACTIVE_COMPARATOR; Interventions: Other: Dental services delivered by the Indian Health Service. | Intervention Type: DEVICE; Name: Fluoride varnish; Assigned to Arm(s): COHS administered fluoride varnish and oral health education | Intervention Type: BEHAVIORAL; Name: Oral health education; Assigned to Arm(s): COHS administered fluoride varnish and oral health education | Intervention Type: OTHER; Name: Dental services delivered by the Indian Health Service.; Assigned to Arm(s): Usual care",
"C": "Intervention Type: BEHAVIORAL; Name: Family Spirit curriculum; Assigned to Arm(s): N/A",
"D": "Arm Label: Motivational interviewing and enhanced community services; Type: EXPERIMENTAL; Interventions: Behavioral: Motivational interviewing, Behavioral: Enhanced community services | Arm Label: Enhanced community services; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Enhanced community services | Intervention Type: BEHAVIORAL; Name: Motivational interviewing; Assigned to Arm(s): Motivational interviewing and enhanced community services | Intervention Type: BEHAVIORAL; Name: Enhanced community services; Assigned to Arm(s): Enhanced community services, Motivational interviewing and enhanced community services"
}
|
A
|
[
"NCT03975530",
"NCT01116739",
"NCT00356551",
"NCT01116726"
] | 27,249 |
val
|
NCT03975985
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Effect of Additional Core Stability Exercises on Improving Dynamic Sitting Balance, Trunk Control and Functional Rehabilitation for Subacute Stroke Patients: A Randomized Controlled Trial
Brief Summary: This study assess the effectiveness of core stability exercises performed in subacute phase of stroke. Half of participants will receive conventional physiotherapy, while the other half will receive core stability exercises and core stability exercises plus transcutaneous electrical nerve stimulation (TENS).
|
{
"A": "Arm Label: Experimental Group; Type: EXPERIMENTAL; Interventions: Behavioral: Together in Movement and Exercise (TIME) Program | Arm Label: Wait-listed Control Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Together in Movement and Exercise (TIME) Program; Assigned to Arm(s): Experimental Group",
"B": "Arm Label: Active tDCS + robotic therapy + physical therapy; Type: ACTIVE_COMPARATOR; Interventions: Device: Robotic Therapy, Device: Active tDCS, Other: Physical Therapy | Arm Label: sham tDCS + robotic therapy + physical therapy; Type: ACTIVE_COMPARATOR; Interventions: Device: Robotic Therapy, Device: Sham tDCS, Other: Physical Therapy | Arm Label: sham tDCS + physical therapy + occupational therapy; Type: EXPERIMENTAL; Interventions: Device: Sham tDCS, Other: Physical Therapy, Other: Occupational Therapy | Intervention Type: DEVICE; Name: Robotic Therapy; Assigned to Arm(s): Active tDCS + robotic therapy + physical therapy, sham tDCS + robotic therapy + physical therapy | Intervention Type: DEVICE; Name: Active tDCS; Assigned to Arm(s): Active tDCS + robotic therapy + physical therapy | Intervention Type: DEVICE; Name: Sham tDCS; Assigned to Arm(s): sham tDCS + physical therapy + occupational therapy, sham tDCS + robotic therapy + physical therapy | Intervention Type: OTHER; Name: Physical Therapy; Assigned to Arm(s): Active tDCS + robotic therapy + physical therapy, sham tDCS + physical therapy + occupational therapy, sham tDCS + robotic therapy + physical therapy | Intervention Type: OTHER; Name: Occupational Therapy; Assigned to Arm(s): sham tDCS + physical therapy + occupational therapy",
"C": "Arm Label: Core stability exercises; Type: EXPERIMENTAL; Interventions: Other: Core stability exercises (CSE), Other: Conventional Physiotherapy | Arm Label: Conventional physiotherapy (CP); Type: ACTIVE_COMPARATOR; Interventions: Other: Conventional Physiotherapy | Intervention Type: OTHER; Name: Core stability exercises (CSE); Assigned to Arm(s): Core stability exercises | Intervention Type: OTHER; Name: Conventional Physiotherapy; Assigned to Arm(s): Conventional physiotherapy (CP), Core stability exercises",
"D": "Arm Label: transcranial direct current stim; Type: EXPERIMENTAL; Interventions: Device: transcranial direct current stim (tDCS) | Arm Label: sham tDCS; Type: PLACEBO_COMPARATOR; Interventions: Device: transcranial direct current stim (tDCS) | Intervention Type: DEVICE; Name: transcranial direct current stim (tDCS); Assigned to Arm(s): sham tDCS, transcranial direct current stim"
}
|
C
|
[
"NCT03122626",
"NCT02416791",
"NCT03975985",
"NCT01807637"
] | 27,250 |
val
|
NCT03976063
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Tocolysis in the Management of Preterm Premature Rupture of Membranes Before 34 Weeks of Gestation: a Double-blinded Randomized Controlled Trial
Brief Summary: The purpose of this study is to assess whether short-term (48 hr) tocolysis reduces perinatal morti-morbidity in cases of PPROM at 22 to 33 completed weeks' gestation.
|
{
"A": "Intervention Type: DRUG; Name: indomethacin; Assigned to Arm(s): N/A",
"B": "Arm Label: Utrogestan; Type: ACTIVE_COMPARATOR; Interventions: Drug: utrogestan | Arm Label: Nifedipine; Type: PLACEBO_COMPARATOR; Interventions: Drug: Nifedipine | Intervention Type: DRUG; Name: utrogestan; Assigned to Arm(s): Utrogestan | Intervention Type: DRUG; Name: Nifedipine; Assigned to Arm(s): Nifedipine",
"C": "Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Drug: Magnesium sulfate | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Oral Nifedipine or placebo | Intervention Type: DRUG; Name: Magnesium sulfate; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Oral Nifedipine or placebo; Assigned to Arm(s): 2",
"D": "Arm Label: Nifedipine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Nifedipine | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo of Nifedipine | Intervention Type: DRUG; Name: Nifedipine; Assigned to Arm(s): Nifedipine | Intervention Type: DRUG; Name: Placebo of Nifedipine; Assigned to Arm(s): Placebo"
}
|
D
|
[
"NCT00466128",
"NCT01985594",
"NCT00306462",
"NCT03976063"
] | 27,251 |
val
|
NCT03978429
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Cluster Randomized, Parallel-group, Superiority Study to Compare the Effectiveness of a Community-based mHealth Strategy Versus Enhanced Usual Care in the Detection and Management of Pre-eclampsia/Eclampsia in Tanzania
Brief Summary: The core of this study is a cluster randomized controlled trial (RCT) of antenatal clinics which are located in four districts in Tanzania. We are conducting an effectiveness (pragmatic) rather than an efficacy (explanatory) trial because we are looking to measure the degree of benefit under 'real world' conditions. Although pragmatic and carried out in real world conditions, the proposed size and scope of the trial will allow us to achieve a robust evaluation of outcomes and determine the effectiveness of our intervention. A cluster design is the most appropriate type of methodology (rather than individual randomization by pregnant woman) as the intervention can be delivered to the entire health facility (of those facilities in the intervention group). The intervention is to implement an mHealth strategy to improve detection and management of PE (pre-eclampsia). This study is a multi-level, mixed-methods design that includes a cluster-randomized controlled trial (RCT) of antenatal clinics in rural Tanzania. Thirty health facilities have been randomized to control facilities and thirty facilities have been randomized to intervention clinics. All randomized clinics have upgraded antenatal care (ANC) and skilled birth attendants present. Nurses in the intervention clinics in this cluster arm will receive mHealth-based education in detection and management of PE and will be instructed and encouraged to follow a guideline-driven approach supported by mHealth (educational modules that provide decision support and reminders through the facility smartphone/tablet). At all antenatal visits, pregnant women will have their blood pressures measured and urine assessed for proteinuria, and, the result will be automatically sent by SMS (short message service) with a unique patient identifier to a central site for monitoring and tracking. Community Health Workers (CHWs) linked to the facility site and local communities will be instructed on which women to have follow-up visits within their communities. For all those women found to be at risk for PE (as well as other high risk maternal conditions), an SMS will be sent to the CHW, and, the nurses at the ANC recommending timely follow-up and protocol steps for management at that facility or for transfer for further monitoring and management at a higher-level facility. The nurses participating in the study have been drawn from the health facilities themselves, in both control and intervention arms. Quantitative data will be collected on an ongoing basis through the mobile platform. Women are eligible for recruitment between 15 weeks and 36 weeks gestation.
|
{
"A": "Arm Label: AH Telemonitoring; Type: EXPERIMENTAL; Interventions: Device: Self measurement of blood pressure | Intervention Type: DEVICE; Name: Self measurement of blood pressure; Assigned to Arm(s): AH Telemonitoring",
"B": "Arm Label: Intervention Arm; Type: EXPERIMENTAL; Interventions: Other: Community-based Pre-eclampsia/Eclampsia Detection and Management, Other: Strengthened Referral Network from Community to Referral hospital levels | Arm Label: Enhanced Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Community-based Pre-eclampsia/Eclampsia Detection and Management; Assigned to Arm(s): Intervention Arm | Intervention Type: OTHER; Name: Strengthened Referral Network from Community to Referral hospital levels; Assigned to Arm(s): Intervention Arm",
"C": "Arm Label: Arm A: Conical then Cylindrical; Type: EXPERIMENTAL; Interventions: Device: Non-invasive BP recording with conical Ultracheck Curve BP cuff, Device: Non-invasive BP recording with traditional cylindrical BP cuff, Other: Direct invasive arterial pressure | Arm Label: Arm B: Cylindrical then Conical; Type: ACTIVE_COMPARATOR; Interventions: Device: Non-invasive BP recording with conical Ultracheck Curve BP cuff, Device: Non-invasive BP recording with traditional cylindrical BP cuff, Other: Direct invasive arterial pressure | Intervention Type: DEVICE; Name: Non-invasive BP recording with conical Ultracheck Curve BP cuff; Assigned to Arm(s): Arm A: Conical then Cylindrical, Arm B: Cylindrical then Conical | Intervention Type: DEVICE; Name: Non-invasive BP recording with traditional cylindrical BP cuff; Assigned to Arm(s): Arm A: Conical then Cylindrical, Arm B: Cylindrical then Conical | Intervention Type: OTHER; Name: Direct invasive arterial pressure; Assigned to Arm(s): Arm A: Conical then Cylindrical, Arm B: Cylindrical then Conical",
"D": "Arm Label: telemonitoring group (TM); Type: EXPERIMENTAL; Interventions: Device: Telemonitoring | Arm Label: Patient self-monitoring group (PSM); Type: ACTIVE_COMPARATOR; Interventions: Device: Telemonitoring | Arm Label: control group (CC); Type: NO_INTERVENTION; Interventions: N/A | Arm Label: CAPROM - Group 1; Type: EXPERIMENTAL; Interventions: Other: Longitudinal CV profiling during pregnancy and before and after the start/switch of antihypertensive medication | Arm Label: CAPROM - Group 2; Type: EXPERIMENTAL; Interventions: Other: CV profiling before and after the start/switch of antihypertensive medication | Intervention Type: DEVICE; Name: Telemonitoring; Assigned to Arm(s): Patient self-monitoring group (PSM), telemonitoring group (TM) | Intervention Type: OTHER; Name: Longitudinal CV profiling during pregnancy and before and after the start/switch of antihypertensive medication; Assigned to Arm(s): CAPROM - Group 1 | Intervention Type: OTHER; Name: CV profiling before and after the start/switch of antihypertensive medication; Assigned to Arm(s): CAPROM - Group 2"
}
|
B
|
[
"NCT03648645",
"NCT03978429",
"NCT03222414",
"NCT04031430"
] | 27,252 |
val
|
NCT03979313
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Late Preterm and Term Infants (MELODY)
Brief Summary: The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and entering their first RSV season.
|
{
"A": "Arm Label: RSVpreF vaccine; Type: EXPERIMENTAL; Interventions: Biological: RSVpreF | Arm Label: Placebo dose; Type: PLACEBO_COMPARATOR; Interventions: Biological: Placebo | Intervention Type: BIOLOGICAL; Name: RSVpreF; Assigned to Arm(s): RSVpreF vaccine | Intervention Type: BIOLOGICAL; Name: Placebo; Assigned to Arm(s): Placebo dose",
"B": "Arm Label: MEDI8897; Type: EXPERIMENTAL; Interventions: Drug: MEDI8897 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: MEDI8897; Assigned to Arm(s): MEDI8897 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"C": "Arm Label: Palivizumab; Type: ACTIVE_COMPARATOR; Interventions: Drug: Palivizumab | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: Palivizumab; Assigned to Arm(s): Palivizumab | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo",
"D": "Arm Label: MEDI8897; Type: EXPERIMENTAL; Interventions: Drug: MEDI8897 | Arm Label: Palivizumab; Type: ACTIVE_COMPARATOR; Interventions: Drug: Palivizumab | Intervention Type: DRUG; Name: MEDI8897; Assigned to Arm(s): MEDI8897 | Intervention Type: DRUG; Name: Palivizumab; Assigned to Arm(s): Palivizumab"
}
|
B
|
[
"NCT04424316",
"NCT03979313",
"NCT02442427",
"NCT03959488"
] | 27,253 |
val
|
NCT03979365
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Prospective, Randomized, Multicenter, Open-Label, Pilot Study to Investigate Medication Adherence & Patient Reported Symptom Occurrence & Interference w/ Daily Life Comparing Envarsus XR® & Immediate Release Tacrolimus in Adult Renal Transplant Recipients (SIMPLE)
Brief Summary: The purpose of this study is to compare once-daily tacrolimus extended-release (Envarsus XR®) to twice-daily immediate release tacrolimus to find out if people taking tacrolimus extended release (Envarsus XR®) report fewer side effects, increased medication compliance and higher scores on quality of life assessments compared to people taking twice daily tacrolimus immediate release.
|
{
"A": "Arm Label: With Med-O-Wheel™; Type: N/A; Interventions: N/A | Arm Label: With out Med-O-Wheel™; Type: N/A; Interventions: N/A",
"B": "Arm Label: Tacrolimus twice-daily; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tacrolimus twice daily | Arm Label: Envarsus XR; Type: ACTIVE_COMPARATOR; Interventions: Drug: Envarsus XR | Intervention Type: DRUG; Name: Envarsus XR; Assigned to Arm(s): Envarsus XR | Intervention Type: DRUG; Name: Tacrolimus twice daily; Assigned to Arm(s): Tacrolimus twice-daily",
"C": "Arm Label: Standard of Care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: mHealth Intervention; Type: EXPERIMENTAL; Interventions: Other: mHealth Intervention | Intervention Type: OTHER; Name: mHealth Intervention; Assigned to Arm(s): mHealth Intervention",
"D": "Arm Label: Patient education program; Type: EXPERIMENTAL; Interventions: Behavioral: Patient education program | Arm Label: Standard care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Patient education program; Assigned to Arm(s): Patient education program"
}
|
B
|
[
"NCT01709097",
"NCT03979365",
"NCT03427008",
"NCT01184937"
] | 27,254 |
val
|
NCT03981783
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Comprehensive Health Informatics Engagement Framework for Pulmonary Rehab
Brief Summary: Previous studies clearly established clinical benefits of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease however uptake and completion rate of pulmonary rehabilitation programs by these patients is limited by multiple barriers. The goal of this project to systematically evaluate impact of Comprehensive Health Informatics Engagement Framework for Pulmonary Rehabilitation (CHIEF-PR) in a randomized controlled trial. The main hypothesis is that CHIEF-PR will result in significantly higher rates of completion of a comprehensive pulmonary rehabilitation program.
|
{
"A": "Arm Label: 1: i-DSMP; Type: EXPERIMENTAL; Interventions: Behavioral: Internet DSMP | Arm Label: 2: f-DSMP; Type: EXPERIMENTAL; Interventions: Behavioral: Face-to-Face Dyspnea Self-management | Arm Label: 3: AC; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Attention Control | Intervention Type: BEHAVIORAL; Name: Internet DSMP; Assigned to Arm(s): 1: i-DSMP | Intervention Type: BEHAVIORAL; Name: Face-to-Face Dyspnea Self-management; Assigned to Arm(s): 2: f-DSMP | Intervention Type: BEHAVIORAL; Name: Attention Control; Assigned to Arm(s): 3: AC",
"B": "Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Telerehabilitation | Intervention Type: BEHAVIORAL; Name: Telerehabilitation; Assigned to Arm(s): Intervention",
"C": "Arm Label: Best available care (BAC); Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Best available care (BAC) | Arm Label: Telerehabilitation (TH); Type: EXPERIMENTAL; Interventions: Behavioral: Telerehabilitation (TH) | Intervention Type: BEHAVIORAL; Name: Best available care (BAC); Assigned to Arm(s): Best available care (BAC) | Intervention Type: BEHAVIORAL; Name: Telerehabilitation (TH); Assigned to Arm(s): Telerehabilitation (TH)",
"D": "Arm Label: CHF patients, IVR-Enhanced Care; Type: EXPERIMENTAL; Interventions: Behavioral: IVR-Enhanced Care | Arm Label: COPD patients, IVR-Enhanced Care; Type: EXPERIMENTAL; Interventions: Behavioral: IVR-Enhanced Care | Arm Label: CHF patients, Usual Discharge Care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: COPD patients, Usual Discharge Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: IVR-Enhanced Care; Assigned to Arm(s): CHF patients, IVR-Enhanced Care, COPD patients, IVR-Enhanced Care"
}
|
C
|
[
"NCT00461162",
"NCT03914027",
"NCT03981783",
"NCT01135381"
] | 27,255 |
val
|
NCT03981783
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Comprehensive Health Informatics Engagement Framework for Pulmonary Rehab
Brief Summary: Previous studies clearly established clinical benefits of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease however uptake and completion rate of pulmonary rehabilitation programs by these patients is limited by multiple barriers. The goal of this project to systematically evaluate impact of Comprehensive Health Informatics Engagement Framework for Pulmonary Rehabilitation (CHIEF-PR) in a randomized controlled trial. The main hypothesis is that CHIEF-PR will result in significantly higher rates of completion of a comprehensive pulmonary rehabilitation program.
|
{
"A": "Arm Label: Telerehabilitation; Type: EXPERIMENTAL; Interventions: Behavioral: Exercise training at home, Behavioral: Telemonitoring and education/self-management | Arm Label: Unsupervised exercise training at home; Type: EXPERIMENTAL; Interventions: Behavioral: Exercise training at home | Arm Label: Usual care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Exercise training at home; Assigned to Arm(s): Telerehabilitation, Unsupervised exercise training at home | Intervention Type: BEHAVIORAL; Name: Telemonitoring and education/self-management; Assigned to Arm(s): Telerehabilitation",
"B": "Arm Label: Self-Control; Type: ACTIVE_COMPARATOR; Interventions: Other: Ergometer Training | Arm Label: Motivation; Type: EXPERIMENTAL; Interventions: Other: Ergometer Training, Other: Motivation | Intervention Type: OTHER; Name: Ergometer Training; Assigned to Arm(s): Motivation, Self-Control | Intervention Type: OTHER; Name: Motivation; Assigned to Arm(s): Motivation",
"C": "Arm Label: Best available care (BAC); Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Best available care (BAC) | Arm Label: Telerehabilitation (TH); Type: EXPERIMENTAL; Interventions: Behavioral: Telerehabilitation (TH) | Intervention Type: BEHAVIORAL; Name: Best available care (BAC); Assigned to Arm(s): Best available care (BAC) | Intervention Type: BEHAVIORAL; Name: Telerehabilitation (TH); Assigned to Arm(s): Telerehabilitation (TH)",
"D": "Arm Label: HappyAir Group; Type: EXPERIMENTAL; Interventions: Other: Pulmonary Care Web-Based App (HappyAir App) | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Pulmonary Care Web-Based App (HappyAir App); Assigned to Arm(s): HappyAir Group"
}
|
C
|
[
"NCT02258646",
"NCT01987544",
"NCT03981783",
"NCT04479930"
] | 27,256 |
val
|
NCT03982381
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Multicenter, Register-based, Randomized, Controlled Trial Comparing Dapagliflozin with Metformin Treatment in Early Stage Type 2 Diabetes Patients by Assessing Mortality and Macro- and Microvascular Complications
Brief Summary: A real-world, nationwide, register-based, randomised trial (RRCT) comparing SGLT2 inhibitors with metformin as standard treatment in early typ 2 diabetes. An open-label trial addressing efficacy with respect to clinically important macro- and microvascular events.
|
{
"A": "Arm Label: Metformin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Metformin | Arm Label: Dapagliflozin; Type: EXPERIMENTAL; Interventions: Drug: Dapagliflozin 10 MG | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): Metformin | Intervention Type: DRUG; Name: Dapagliflozin 10 MG; Assigned to Arm(s): Dapagliflozin",
"B": "Intervention Type: DRUG; Name: vildagliptin; Assigned to Arm(s): N/A",
"C": "Arm Label: Metformin,lifestyle counselling; Type: ACTIVE_COMPARATOR; Interventions: Drug: rosiglitazone, Drug: metformin, Drug: Anti-diabetic medications | Intervention Type: DRUG; Name: rosiglitazone; Assigned to Arm(s): Metformin,lifestyle counselling | Intervention Type: DRUG; Name: metformin; Assigned to Arm(s): Metformin,lifestyle counselling | Intervention Type: DRUG; Name: Anti-diabetic medications; Assigned to Arm(s): Metformin,lifestyle counselling",
"D": "Arm Label: 1.5 mg LY2189265; Type: EXPERIMENTAL; Interventions: Drug: LY2189265, Drug: Metformin | Arm Label: Liraglutide; Type: ACTIVE_COMPARATOR; Interventions: Drug: Liraglutide, Drug: Metformin | Intervention Type: DRUG; Name: LY2189265; Assigned to Arm(s): 1.5 mg LY2189265 | Intervention Type: DRUG; Name: Liraglutide; Assigned to Arm(s): Liraglutide | Intervention Type: DRUG; Name: Metformin; Assigned to Arm(s): 1.5 mg LY2189265, Liraglutide"
}
|
A
|
[
"NCT03982381",
"NCT00120536",
"NCT00373178",
"NCT01624259"
] | 27,257 |
val
|
NCT03985449
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Implementation of Uterine Fibroid Option Grid Patient Decision Aids Across Five Organizational Settings: a Randomized Stepped-wedge Study
Brief Summary: UPFRONT is a study that aims to use two implementation frameworks - the Consolidated Framework for Implementation Research and the Normalization Process Theory - to guide the implementation of a uterine fibroid patient decision aid, known as Option Grid, at five diverse gynecology settings across the United States. Option Grid provides evidence-based information on the various treatment options to help women across socioeconomic strata with symptomatic uterine fibroids make a preference-sensitive decision.
|
{
"A": "Arm Label: Intervention Group; Type: EXPERIMENTAL; Interventions: Behavioral: Education Counseling Session for PSA Screening | Arm Label: Control Group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: General Health Counseling Coaching | Intervention Type: BEHAVIORAL; Name: Education Counseling Session for PSA Screening; Assigned to Arm(s): Intervention Group | Intervention Type: BEHAVIORAL; Name: General Health Counseling Coaching; Assigned to Arm(s): Control Group",
"B": "Arm Label: Active Implementation phase; Type: OTHER; Interventions: Other: Uterine Fibroid Option Grid encounter patient decision aid (text only), Other: Uterine Fibroid Option Grid encounter patient decision aid (text + Pictures), Other: Uterine Fibroid Option Grid encounter patient decision aid (online) | Intervention Type: OTHER; Name: Uterine Fibroid Option Grid encounter patient decision aid (text only); Assigned to Arm(s): Active Implementation phase | Intervention Type: OTHER; Name: Uterine Fibroid Option Grid encounter patient decision aid (text + Pictures); Assigned to Arm(s): Active Implementation phase | Intervention Type: OTHER; Name: Uterine Fibroid Option Grid encounter patient decision aid (online); Assigned to Arm(s): Active Implementation phase",
"C": "Arm Label: communication skills training; Type: EXPERIMENTAL; Interventions: Behavioral: patient training in shared decision making | Arm Label: cognitive training; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: cognitive training | Intervention Type: BEHAVIORAL; Name: patient training in shared decision making; Assigned to Arm(s): communication skills training | Intervention Type: BEHAVIORAL; Name: cognitive training; Assigned to Arm(s): cognitive training",
"D": "Arm Label: SCC1--high intensity supervision; Type: EXPERIMENTAL; Interventions: Behavioral: safer conception counseling | Arm Label: SCC2-- low intensity supervision; Type: EXPERIMENTAL; Interventions: Behavioral: safer conception counseling | Arm Label: Usual care family planning services; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: safer conception counseling; Assigned to Arm(s): SCC1--high intensity supervision, SCC2-- low intensity supervision"
}
|
B
|
[
"NCT03726320",
"NCT03985449",
"NCT00885716",
"NCT03167879"
] | 27,258 |
val
|
NCT03986047
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of Thermal Therapy in Combination With Exercises to Relieve Acute Low Back Pain
Brief Summary: Low back pain (LBP) ranks among the first diseases in term of years lived with disability. The latest Clinical Guideline from the American College of Physicians for acute LBP recommends to select "nonpharmacologic treatment with superficial heat, massage, acupuncture or spinal manipulation". The application of superficial heat ("thermal therapy") may provide enough pain relief in the acute phase to remain active, which is recommended to prevent the development of chronicity. However, no studies have tested if the combination of heat and exercises provide additional benefit on short, middle and long-term follow-up in people with acute LBP.
Hence, the main objective of this study is to determine the immediate, short-, middle- and long-term effect of continuous low-level thermal therapy in combination or not with exercises on pain, disability, and physical activity level in people with acute LBP.
Project hypothesis : The Thermal care + Exercises group will show greater improvement in pain, disability and physical activity level than both Thermal care and Control groups for immediate, short-, middle- and long-term follow-ups.
Sixty individuals with acute LBP will be recruited. This study will include six assessments over 6 months. At the baseline evaluation, participants will complete questionnaires on symptoms, disability, pain-related fear and self-efficacy. Afterwards, participants will be randomly assigned to one of three intervention programs: 1) Thermal care group, 2) Exercises + Thermal care group, and 3) Control group. They will immediately meet a physical therapist to review and perform their assigned program.
Participants will then take part in their assigned 7-day intervention program, during which they will wear a fitness wristband to track physical activity level. Finally, the same outcomes will be reassessed to determine the effect of intervention at 1 week, 1 month, 3 months and 6 months after baseline.
|
{
"A": "Arm Label: Low Back Only; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Low Back Only | Arm Label: Low Back+Hip; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Low Back+Hip | Intervention Type: PROCEDURE; Name: Low Back Only; Assigned to Arm(s): Low Back Only | Intervention Type: PROCEDURE; Name: Low Back+Hip; Assigned to Arm(s): Low Back+Hip",
"B": "Arm Label: Specific resistance training; Type: ACTIVE_COMPARATOR; Interventions: Other: Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck; Assigned to Arm(s): Specific resistance training",
"C": "Arm Label: S-A; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Stay-active care | Arm Label: S-A+stretch; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Stay-active care+stretching | Arm Label: S-A+stretch+manther; Type: EXPERIMENTAL; Interventions: Procedure: Stay-active+stretching+manual therapy | Arm Label: S-A+stretch+manther+sterinject; Type: EXPERIMENTAL; Interventions: Procedure: Stay-active+stretching+manual therapy+steroid injections | Intervention Type: PROCEDURE; Name: Stay-active care; Assigned to Arm(s): S-A | Intervention Type: PROCEDURE; Name: Stay-active care+stretching; Assigned to Arm(s): S-A+stretch | Intervention Type: PROCEDURE; Name: Stay-active+stretching+manual therapy; Assigned to Arm(s): S-A+stretch+manther | Intervention Type: PROCEDURE; Name: Stay-active+stretching+manual therapy+steroid injections; Assigned to Arm(s): S-A+stretch+manther+sterinject",
"D": "Arm Label: Thermal care; Type: EXPERIMENTAL; Interventions: Device: Thermal care, Behavioral: Education for the management of acute low back pain | Arm Label: Thermal care + exercises; Type: EXPERIMENTAL; Interventions: Device: Thermal care, Other: Exercises, Behavioral: Education for the management of acute low back pain | Arm Label: Control; Type: SHAM_COMPARATOR; Interventions: Device: Sham, Behavioral: Education for the management of acute low back pain | Intervention Type: DEVICE; Name: Thermal care; Assigned to Arm(s): Thermal care, Thermal care + exercises | Intervention Type: OTHER; Name: Exercises; Assigned to Arm(s): Thermal care + exercises | Intervention Type: DEVICE; Name: Sham; Assigned to Arm(s): Control | Intervention Type: BEHAVIORAL; Name: Education for the management of acute low back pain; Assigned to Arm(s): Control, Thermal care, Thermal care + exercises"
}
|
D
|
[
"NCT03550014",
"NCT01071980",
"NCT00923429",
"NCT03986047"
] | 27,259 |
val
|
NCT03986931
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Pharmacist Intervention for Monitoring and Treating Hypertension Using Bidirectional Texting
Brief Summary: Bidirectional texting is an effective way to collect home blood pressure (BP) measurements from subjects, but collecting BP measurements and sending them to physicians does not necessarily lead to decreased BP. Pharmacist interventions have been successful in decreasing subject BP. However, pharmacists are expensive, and in successful interventions, spent a substantial amount of time collecting home BP measurements. In this study, a proven pharmacist intervention will be added to a bidirectional texting program to determine if a combined pharmacist-bidirectional texting intervention is successful at decreasing subject BP and increasing subject BP treatment intensification in a cost-effective manner. This study will be a cluster-randomized, controlled trial of a new intervention.
|
{
"A": "Arm Label: Arm 1; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Arm 2; Type: EXPERIMENTAL; Interventions: Behavioral: Nurse Behavioral intervention with Home BP Telemonitoring | Arm Label: Arm 3; Type: EXPERIMENTAL; Interventions: Behavioral: Nurse Medication Management with Home BP Telemonitoring | Arm Label: Arm 4; Type: EXPERIMENTAL; Interventions: Behavioral: Nurse Combined intervention with Home BP Telemonitoring | Intervention Type: BEHAVIORAL; Name: Nurse Behavioral intervention with Home BP Telemonitoring; Assigned to Arm(s): Arm 2 | Intervention Type: BEHAVIORAL; Name: Nurse Medication Management with Home BP Telemonitoring; Assigned to Arm(s): Arm 3 | Intervention Type: BEHAVIORAL; Name: Nurse Combined intervention with Home BP Telemonitoring; Assigned to Arm(s): Arm 4",
"B": "Arm Label: Telepharmacist intervention; Type: EXPERIMENTAL; Interventions: Behavioral: Telepharmacist intervention | Arm Label: Usual care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Telepharmacist intervention; Assigned to Arm(s): Telepharmacist intervention",
"C": "Arm Label: Pharmacist-Bidirectional Texting Group; Type: EXPERIMENTAL; Interventions: Other: Experimental: Pharmacist-Bidirectional Texting Group | Arm Label: Control Group; Type: ACTIVE_COMPARATOR; Interventions: Other: Active Comparator: Control Group | Intervention Type: OTHER; Name: Experimental: Pharmacist-Bidirectional Texting Group; Assigned to Arm(s): Pharmacist-Bidirectional Texting Group | Intervention Type: OTHER; Name: Active Comparator: Control Group; Assigned to Arm(s): Control Group",
"D": "Arm Label: Usual care (UC); Type: PLACEBO_COMPARATOR; Interventions: Other: Usual care | Arm Label: Self-management; Type: EXPERIMENTAL; Interventions: Device: Self-management | Arm Label: PCTM intervention; Type: EXPERIMENTAL; Interventions: Other: PCTM intervention | Intervention Type: OTHER; Name: Usual care; Assigned to Arm(s): Usual care (UC) | Intervention Type: DEVICE; Name: Self-management; Assigned to Arm(s): Self-management | Intervention Type: OTHER; Name: PCTM intervention; Assigned to Arm(s): PCTM intervention"
}
|
C
|
[
"NCT00237692",
"NCT02512276",
"NCT03986931",
"NCT02919033"
] | 27,260 |
val
|
NCT03987165
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Effect of Music Therapy on Newborns
Brief Summary: The clinical study is evaluating the impact of music therapy on neonates, specifically infants with neonatal opioid withdrawal syndrome (NOWS). The goal is to study the effect of music therapy on an infant's behavioral (i.e feeding patterns, sleep patterns, severity of withdrawal) and physiological systems (i.e. heart rate, respiratory rate). The investigators are also studying the impact of music therapy on the infant's utilization of resources (i.e. total opioid usage and total length of stay).
|
{
"A": "Arm Label: sublingual buprenorphine; Type: EXPERIMENTAL; Interventions: Drug: sublingual buprenorphine | Arm Label: oral morphine; Type: ACTIVE_COMPARATOR; Interventions: Drug: oral morphine | Intervention Type: DRUG; Name: sublingual buprenorphine; Assigned to Arm(s): sublingual buprenorphine | Intervention Type: DRUG; Name: oral morphine; Assigned to Arm(s): oral morphine",
"B": "Arm Label: Oral morphine sulfate; Type: ACTIVE_COMPARATOR; Interventions: Drug: Morphine Sulfate | Arm Label: Buprenorphine; Type: EXPERIMENTAL; Interventions: Drug: Buprenorphine | Intervention Type: DRUG; Name: Buprenorphine; Assigned to Arm(s): Buprenorphine | Intervention Type: DRUG; Name: Morphine Sulfate; Assigned to Arm(s): Oral morphine sulfate",
"C": "Arm Label: 1 (Phenobarbital and Methadone); Type: ACTIVE_COMPARATOR; Interventions: Drug: Methadone | Arm Label: 2 (Phenobarbital and Diluted Deodorized Tincture of Opium); Type: ACTIVE_COMPARATOR; Interventions: Drug: Diluted Deodorized Tincture of Opium | Intervention Type: DRUG; Name: Methadone; Assigned to Arm(s): 1 (Phenobarbital and Methadone) | Intervention Type: DRUG; Name: Diluted Deodorized Tincture of Opium; Assigned to Arm(s): 2 (Phenobarbital and Diluted Deodorized Tincture of Opium)",
"D": "Arm Label: Music Therapy; Type: EXPERIMENTAL; Interventions: Other: Music Therapy | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Music Therapy; Assigned to Arm(s): Music Therapy"
}
|
D
|
[
"NCT01452789",
"NCT01708707",
"NCT01723722",
"NCT03987165"
] | 27,261 |
val
|
NCT03987165
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Effect of Music Therapy on Newborns
Brief Summary: The clinical study is evaluating the impact of music therapy on neonates, specifically infants with neonatal opioid withdrawal syndrome (NOWS). The goal is to study the effect of music therapy on an infant's behavioral (i.e feeding patterns, sleep patterns, severity of withdrawal) and physiological systems (i.e. heart rate, respiratory rate). The investigators are also studying the impact of music therapy on the infant's utilization of resources (i.e. total opioid usage and total length of stay).
|
{
"A": "Arm Label: Music Therapy; Type: EXPERIMENTAL; Interventions: Other: Music Therapy | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Music Therapy; Assigned to Arm(s): Music Therapy",
"B": "Arm Label: Phenobarbital; Type: EXPERIMENTAL; Interventions: Drug: Phenobarbital | Arm Label: Chlorpromazine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Chlorpromazine | Arm Label: Morphine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Morphine | Intervention Type: DRUG; Name: Phenobarbital; Assigned to Arm(s): Phenobarbital | Intervention Type: DRUG; Name: Chlorpromazine; Assigned to Arm(s): Chlorpromazine | Intervention Type: DRUG; Name: Morphine; Assigned to Arm(s): Morphine",
"C": "Arm Label: Song of Kin; Type: EXPERIMENTAL; Interventions: Behavioral: Song of Kin | Arm Label: Gato box; Type: EXPERIMENTAL; Interventions: Other: Gato box | Arm Label: Ocean disc; Type: EXPERIMENTAL; Interventions: Other: Ocean disc | Arm Label: Contingent singing; Type: EXPERIMENTAL; Interventions: Other: Contingent singing | Arm Label: Tonal Vocal holding; Type: EXPERIMENTAL; Interventions: Other: Tonal Vocal holding | Arm Label: Muted shaker; Type: EXPERIMENTAL; Interventions: Other: Muted shaker | Intervention Type: BEHAVIORAL; Name: Song of Kin; Assigned to Arm(s): Song of Kin | Intervention Type: OTHER; Name: Gato box; Assigned to Arm(s): Gato box | Intervention Type: OTHER; Name: Ocean disc; Assigned to Arm(s): Ocean disc | Intervention Type: OTHER; Name: Contingent singing; Assigned to Arm(s): Contingent singing | Intervention Type: OTHER; Name: Tonal Vocal holding; Assigned to Arm(s): Tonal Vocal holding | Intervention Type: OTHER; Name: Muted shaker; Assigned to Arm(s): Muted shaker",
"D": "Arm Label: Methadone; Type: N/A; Interventions: Drug: Methadone | Intervention Type: DRUG; Name: Methadone; Assigned to Arm(s): Methadone"
}
|
A
|
[
"NCT03987165",
"NCT02810782",
"NCT03533985",
"NCT01754324"
] | 27,262 |
val
|
NCT03987165
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Effect of Music Therapy on Newborns
Brief Summary: The clinical study is evaluating the impact of music therapy on neonates, specifically infants with neonatal opioid withdrawal syndrome (NOWS). The goal is to study the effect of music therapy on an infant's behavioral (i.e feeding patterns, sleep patterns, severity of withdrawal) and physiological systems (i.e. heart rate, respiratory rate). The investigators are also studying the impact of music therapy on the infant's utilization of resources (i.e. total opioid usage and total length of stay).
|
{
"A": "Arm Label: Standard therapy plus Aromatherapy; Type: EXPERIMENTAL; Interventions: Drug: lavender and chamomile essential oils | Arm Label: Standard therapy ALONE; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: lavender and chamomile essential oils; Assigned to Arm(s): Standard therapy plus Aromatherapy",
"B": "Arm Label: Oral glucose solution + maternal holding; Type: EXPERIMENTAL; Interventions: Other: Oral glucose solution + maternal holding | Arm Label: Breastfeeding; Type: EXPERIMENTAL; Interventions: Other: Breastfeeding | Arm Label: Oral glucose solution; Type: ACTIVE_COMPARATOR; Interventions: Other: Oral glucose solution | Arm Label: Oral expressed breastmilk; Type: ACTIVE_COMPARATOR; Interventions: Other: Oral expressed breastmilk | Intervention Type: OTHER; Name: Oral glucose solution + maternal holding; Assigned to Arm(s): Oral glucose solution + maternal holding | Intervention Type: OTHER; Name: Breastfeeding; Assigned to Arm(s): Breastfeeding | Intervention Type: OTHER; Name: Oral glucose solution; Assigned to Arm(s): Oral glucose solution | Intervention Type: OTHER; Name: Oral expressed breastmilk; Assigned to Arm(s): Oral expressed breastmilk",
"C": "Arm Label: Music Therapy; Type: EXPERIMENTAL; Interventions: Other: Music Therapy | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Music Therapy; Assigned to Arm(s): Music Therapy",
"D": "Arm Label: Song of Kin; Type: EXPERIMENTAL; Interventions: Behavioral: Song of Kin | Arm Label: Gato box; Type: EXPERIMENTAL; Interventions: Other: Gato box | Arm Label: Ocean disc; Type: EXPERIMENTAL; Interventions: Other: Ocean disc | Arm Label: Contingent singing; Type: EXPERIMENTAL; Interventions: Other: Contingent singing | Arm Label: Tonal Vocal holding; Type: EXPERIMENTAL; Interventions: Other: Tonal Vocal holding | Arm Label: Muted shaker; Type: EXPERIMENTAL; Interventions: Other: Muted shaker | Intervention Type: BEHAVIORAL; Name: Song of Kin; Assigned to Arm(s): Song of Kin | Intervention Type: OTHER; Name: Gato box; Assigned to Arm(s): Gato box | Intervention Type: OTHER; Name: Ocean disc; Assigned to Arm(s): Ocean disc | Intervention Type: OTHER; Name: Contingent singing; Assigned to Arm(s): Contingent singing | Intervention Type: OTHER; Name: Tonal Vocal holding; Assigned to Arm(s): Tonal Vocal holding | Intervention Type: OTHER; Name: Muted shaker; Assigned to Arm(s): Muted shaker"
}
|
C
|
[
"NCT03097484",
"NCT03389789",
"NCT03987165",
"NCT03533985"
] | 27,263 |
val
|
NCT03987542
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Outcome Following Truncation of Asparaginase in the NOPHO ALL2008 Protocol
Brief Summary: This study aimed to investigate the outcome of patients who had their asparaginase treatment truncated in the NOPHO ALL2008 protocol.
|
{
"A": "Arm Label: I; Type: EXPERIMENTAL; Interventions: Drug: asparaginase, Drug: cyclophosphamide, Drug: cytarabine, Drug: daunorubicin, Drug: mercaptopurine, Drug: Methotrexate, Drug: prednisone, Drug: Vincristine | Arm Label: II; Type: EXPERIMENTAL; Interventions: Drug: dexamethasone, Drug: asparaginase, Drug: cyclophosphamide, Drug: cytarabine, Drug: daunorubicin, Drug: mercaptopurine, Drug: Methotrexate, Drug: Vincristine | Arm Label: Reintensification Arm I; Type: EXPERIMENTAL; Interventions: Drug: Asparaginase, Drug: cyclophosphamide, Drug: cytarabine, Drug: doxorubicin, Drug: mercaptopurine, Drug: Methotrexate, Drug: thioguanine, Drug: Vincristine | Arm Label: Reintensification Arm II; Type: EXPERIMENTAL; Interventions: Drug: Asparaginase, Drug: cyclophosphamide, Drug: cytarabine, Drug: doxorubicin, Drug: mercaptopurine, Drug: Methotrexate, Drug: thioguanine, Drug: Vincristine | Arm Label: Reintensification Arm III; Type: EXPERIMENTAL; Interventions: Drug: Asparaginase, Drug: cytarabine, Drug: doxorubicin, Drug: mercaptopurine, Drug: Methotrexate, Drug: Vincristine | Arm Label: Reintensification Arm IV; Type: EXPERIMENTAL; Interventions: Drug: Etoposide, Drug: Ifosfamide, Drug: Methotrexate, Drug: Vincristine, Drug: Vindesine | Arm Label: Reintensification Arm V; Type: EXPERIMENTAL; Interventions: Drug: Etoposide, Drug: Ifosfamide, Drug: Methotrexate, Drug: Vincristine, Drug: Vindesine | Intervention Type: DRUG; Name: dexamethasone; Assigned to Arm(s): II | Intervention Type: DRUG; Name: asparaginase; Assigned to Arm(s): I, II | Intervention Type: DRUG; Name: Asparaginase; Assigned to Arm(s): Reintensification Arm I, Reintensification Arm II, Reintensification Arm III | Intervention Type: DRUG; Name: cyclophosphamide; Assigned to Arm(s): I, II, Reintensification Arm I, Reintensification Arm II | Intervention Type: DRUG; Name: cytarabine; Assigned to Arm(s): I, II, Reintensification Arm I, Reintensification Arm II, Reintensification Arm III | Intervention Type: DRUG; Name: daunorubicin; Assigned to Arm(s): I, II | Intervention Type: DRUG; Name: doxorubicin; Assigned to Arm(s): Reintensification Arm I, Reintensification Arm II, Reintensification Arm III | Intervention Type: DRUG; Name: Etoposide; Assigned to Arm(s): Reintensification Arm IV, Reintensification Arm V | Intervention Type: DRUG; Name: Ifosfamide; Assigned to Arm(s): Reintensification Arm IV, Reintensification Arm V | Intervention Type: DRUG; Name: mercaptopurine; Assigned to Arm(s): I, II, Reintensification Arm I, Reintensification Arm II, Reintensification Arm III | Intervention Type: DRUG; Name: Methotrexate; Assigned to Arm(s): I, II, Reintensification Arm I, Reintensification Arm II, Reintensification Arm III, Reintensification Arm IV, Reintensification Arm V | Intervention Type: DRUG; Name: prednisone; Assigned to Arm(s): I | Intervention Type: DRUG; Name: thioguanine; Assigned to Arm(s): Reintensification Arm I, Reintensification Arm II | Intervention Type: DRUG; Name: Vincristine; Assigned to Arm(s): I, II, Reintensification Arm I, Reintensification Arm II, Reintensification Arm III, Reintensification Arm IV, Reintensification Arm V | Intervention Type: DRUG; Name: Vindesine; Assigned to Arm(s): Reintensification Arm IV, Reintensification Arm V",
"B": "Arm Label: SC-PEG (Arm A); Type: ACTIVE_COMPARATOR; Interventions: Drug: SC-PEG | Arm Label: Oncaspar (Arm B); Type: ACTIVE_COMPARATOR; Interventions: Drug: Oncaspar | Intervention Type: DRUG; Name: SC-PEG; Assigned to Arm(s): SC-PEG (Arm A) | Intervention Type: DRUG; Name: Oncaspar; Assigned to Arm(s): Oncaspar (Arm B)",
"C": "Arm Label: Exposed; Type: N/A; Interventions: N/A | Arm Label: Unexposed; Type: N/A; Interventions: N/A",
"D": "Arm Label: Intramuscular native E coli L-asparaginase (IM-EC); Type: ACTIVE_COMPARATOR; Interventions: Drug: asparaginase, Drug: cyclophosphamide, Drug: cytarabine, Drug: dexamethasone, Drug: dexrazoxane hydrochloride, Drug: doxorubicin hydrochloride, Drug: etoposide, Drug: leucovorin calcium, Drug: mercaptopurine, Drug: methotrexate, Drug: methylprednisolone, Drug: prednisolone, Drug: therapeutic hydrocortisone, Drug: vincristine sulfate, Radiation: radiation therapy | Arm Label: Intravenous PEG-asparaginase (IV-PEG); Type: EXPERIMENTAL; Interventions: Drug: cyclophosphamide, Drug: cytarabine, Drug: dexamethasone, Drug: dexrazoxane hydrochloride, Drug: doxorubicin hydrochloride, Drug: etoposide, Drug: leucovorin calcium, Drug: mercaptopurine, Drug: methotrexate, Drug: methylprednisolone, Drug: pegaspargase, Drug: prednisolone, Drug: therapeutic hydrocortisone, Drug: vincristine sulfate, Radiation: radiation therapy | Intervention Type: DRUG; Name: asparaginase; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC) | Intervention Type: DRUG; Name: cyclophosphamide; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC), Intravenous PEG-asparaginase (IV-PEG) | Intervention Type: DRUG; Name: cytarabine; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC), Intravenous PEG-asparaginase (IV-PEG) | Intervention Type: DRUG; Name: dexamethasone; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC), Intravenous PEG-asparaginase (IV-PEG) | Intervention Type: DRUG; Name: dexrazoxane hydrochloride; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC), Intravenous PEG-asparaginase (IV-PEG) | Intervention Type: DRUG; Name: doxorubicin hydrochloride; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC), Intravenous PEG-asparaginase (IV-PEG) | Intervention Type: DRUG; Name: etoposide; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC), Intravenous PEG-asparaginase (IV-PEG) | Intervention Type: DRUG; Name: leucovorin calcium; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC), Intravenous PEG-asparaginase (IV-PEG) | Intervention Type: DRUG; Name: mercaptopurine; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC), Intravenous PEG-asparaginase (IV-PEG) | Intervention Type: DRUG; Name: methotrexate; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC), Intravenous PEG-asparaginase (IV-PEG) | Intervention Type: DRUG; Name: methylprednisolone; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC), Intravenous PEG-asparaginase (IV-PEG) | Intervention Type: DRUG; Name: pegaspargase; Assigned to Arm(s): Intravenous PEG-asparaginase (IV-PEG) | Intervention Type: DRUG; Name: prednisolone; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC), Intravenous PEG-asparaginase (IV-PEG) | Intervention Type: DRUG; Name: therapeutic hydrocortisone; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC), Intravenous PEG-asparaginase (IV-PEG) | Intervention Type: DRUG; Name: vincristine sulfate; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC), Intravenous PEG-asparaginase (IV-PEG) | Intervention Type: RADIATION; Name: radiation therapy; Assigned to Arm(s): Intramuscular native E coli L-asparaginase (IM-EC), Intravenous PEG-asparaginase (IV-PEG)"
}
|
C
|
[
"NCT00613457",
"NCT01574274",
"NCT03987542",
"NCT00400946"
] | 27,264 |
val
|
NCT03992066
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 1b, Randomized, Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Vadadustat in Hemodialysis Subjects With Anemia Associated With Chronic Kidney Disease
Brief Summary: This study will be conducted to assess the pharmacokinetics of vadadustat 600, 750, and 900 milligrams daily, and intravenous erythropoiesis-stimulating agent (darbepoetin alfa or epoetin alfa), in hemodialysis participants with anemia associated with chronic kidney disease.
|
{
"A": "Arm Label: GSK1278863; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: Control; Type: OTHER; Interventions: Drug: rhEPO | Intervention Type: DRUG; Name: GSK1278863; Assigned to Arm(s): GSK1278863 | Intervention Type: DRUG; Name: rhEPO; Assigned to Arm(s): Control",
"B": "Arm Label: Vadadustat; Type: EXPERIMENTAL; Interventions: Drug: Vadadustat | Arm Label: Darbepoetin alfa; Type: ACTIVE_COMPARATOR; Interventions: Drug: Darbepoetin alfa | Intervention Type: DRUG; Name: Vadadustat; Assigned to Arm(s): Vadadustat | Intervention Type: DRUG; Name: Darbepoetin alfa; Assigned to Arm(s): Darbepoetin alfa",
"C": "Arm Label: ASP1517 Low dose group; Type: EXPERIMENTAL; Interventions: Drug: roxadustat | Arm Label: ASP1517 Middle dose group; Type: EXPERIMENTAL; Interventions: Drug: roxadustat | Arm Label: ASP1517 High dose group; Type: EXPERIMENTAL; Interventions: Drug: roxadustat | Arm Label: Darbepoetin group; Type: ACTIVE_COMPARATOR; Interventions: Drug: darbepoetin alfa | Intervention Type: DRUG; Name: roxadustat; Assigned to Arm(s): ASP1517 High dose group, ASP1517 Low dose group, ASP1517 Middle dose group | Intervention Type: DRUG; Name: darbepoetin alfa; Assigned to Arm(s): Darbepoetin group",
"D": "Arm Label: Vadadustat 600 mg; Type: EXPERIMENTAL; Interventions: Drug: Vadadustat | Arm Label: Vadadustat 750 mg; Type: EXPERIMENTAL; Interventions: Drug: Vadadustat | Arm Label: Vadadustat 900 mg; Type: EXPERIMENTAL; Interventions: Drug: Vadadustat | Arm Label: Erythropoiesis-stimulating agent; Type: OTHER; Interventions: Drug: Darbepoetin alfa, Drug: Epoetin alfa | Intervention Type: DRUG; Name: Vadadustat; Assigned to Arm(s): Vadadustat 600 mg, Vadadustat 750 mg, Vadadustat 900 mg | Intervention Type: DRUG; Name: Darbepoetin alfa; Assigned to Arm(s): Erythropoiesis-stimulating agent | Intervention Type: DRUG; Name: Epoetin alfa; Assigned to Arm(s): Erythropoiesis-stimulating agent"
}
|
D
|
[
"NCT01977573",
"NCT02680574",
"NCT01888445",
"NCT03992066"
] | 27,265 |
val
|
NCT03992937
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Vaginal Micronized Progesterone or Levonorgestrel-releasing Intrauterine System (LNG-IUS) for Treatment of Non-atypical Endometrial Hyperplasia: A Prospective Randomized Trial
Brief Summary: The purpose of this study is to compare the efficacy of the vaginal micronized progesterone and Levonorgestrel-releasing Intrauterine System for treatment of non-atypical endometrial hyperplasia in premenopausal women.
|
{
"A": "Arm Label: Vaginal Micronized Progesterone; Type: EXPERIMENTAL; Interventions: Drug: Vaginal Micronized Progesterone | Arm Label: LNG-IUS; Type: ACTIVE_COMPARATOR; Interventions: Device: Levonorgestrel-Intrauterine System | Intervention Type: DRUG; Name: Vaginal Micronized Progesterone; Assigned to Arm(s): Vaginal Micronized Progesterone | Intervention Type: DEVICE; Name: Levonorgestrel-Intrauterine System; Assigned to Arm(s): LNG-IUS",
"B": "Arm Label: MA; Type: ACTIVE_COMPARATOR; Interventions: Drug: Megestrol Acetate | Arm Label: LNG-IUS; Type: ACTIVE_COMPARATOR; Interventions: Device: Levonorgestrel-releasing Intrauterine System(LNG-IUS) | Arm Label: MA+LNG-IUS; Type: EXPERIMENTAL; Interventions: Drug: Megestrol Acetate, Device: Levonorgestrel-releasing Intrauterine System(LNG-IUS) | Intervention Type: DRUG; Name: Megestrol Acetate; Assigned to Arm(s): MA, MA+LNG-IUS | Intervention Type: DEVICE; Name: Levonorgestrel-releasing Intrauterine System(LNG-IUS); Assigned to Arm(s): LNG-IUS, MA+LNG-IUS",
"C": "Arm Label: MPA 10 mg per oral cyclic for 6 months; Type: ACTIVE_COMPARATOR; Interventions: Drug: Provera (medroxyprogesterone/progestin) | Arm Label: MPA 10 mg per os continuous 6 months; Type: ACTIVE_COMPARATOR; Interventions: Drug: Provera (medroxyprogesterone) | Arm Label: LNG-IUD for 6 months; Type: ACTIVE_COMPARATOR; Interventions: Device: Mirena (levonorgestrel) | Intervention Type: DRUG; Name: Provera (medroxyprogesterone/progestin); Assigned to Arm(s): MPA 10 mg per oral cyclic for 6 months | Intervention Type: DRUG; Name: Provera (medroxyprogesterone); Assigned to Arm(s): MPA 10 mg per os continuous 6 months | Intervention Type: DEVICE; Name: Mirena (levonorgestrel); Assigned to Arm(s): LNG-IUD for 6 months",
"D": "Arm Label: MPA for EC without progesterone contraindication; Type: ACTIVE_COMPARATOR; Interventions: Drug: Progesterone | Arm Label: MPA+Mirena® for EC without contraindication; Type: EXPERIMENTAL; Interventions: Drug: Progesterone, Device: Mirena® | Arm Label: Mirena® for EC without contraindication; Type: EXPERIMENTAL; Interventions: Device: Mirena® | Arm Label: GnRH agonist+Mirena® for EC with contraindication; Type: ACTIVE_COMPARATOR; Interventions: Device: Mirena®, Drug: GnRH agonist | Arm Label: Mirena® for EC with contraindication; Type: EXPERIMENTAL; Interventions: Device: Mirena® | Arm Label: Mirena® for EAH without progesterone contraindication; Type: ACTIVE_COMPARATOR; Interventions: Device: Mirena® | Arm Label: MPA for EAH without progesterone contraindication; Type: EXPERIMENTAL; Interventions: Drug: Progesterone | Arm Label: Mirena® for EAH with progesterone contraindication; Type: ACTIVE_COMPARATOR; Interventions: Device: Mirena® | Arm Label: GnRH-a+Mirena® for EAH with progesterone contraindication; Type: EXPERIMENTAL; Interventions: Device: Mirena®, Drug: GnRH agonist | Intervention Type: DRUG; Name: Progesterone; Assigned to Arm(s): MPA for EAH without progesterone contraindication, MPA for EC without progesterone contraindication, MPA+Mirena® for EC without contraindication | Intervention Type: DEVICE; Name: Mirena®; Assigned to Arm(s): GnRH agonist+Mirena® for EC with contraindication, GnRH-a+Mirena® for EAH with progesterone contraindication, MPA+Mirena® for EC without contraindication, Mirena® for EAH with progesterone contraindication, Mirena® for EAH without progesterone contraindication, Mirena® for EC with contraindication, Mirena® for EC without contraindication | Intervention Type: DRUG; Name: GnRH agonist; Assigned to Arm(s): GnRH agonist+Mirena® for EC with contraindication, GnRH-a+Mirena® for EAH with progesterone contraindication"
}
|
A
|
[
"NCT03992937",
"NCT03241888",
"NCT01074892",
"NCT03463252"
] | 27,266 |
val
|
NCT03995238
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Optimizing Gait Rehabilitation for Veterans With Non-Traumatic Lower Limb Amputation
Brief Summary: The population of older Veterans with non-traumatic lower limb amputation is growing. Following lower limb amputation, asymmetrical movements persist during walking and likely contribute to disabling sequelae including secondary pain conditions, poor gait efficiency, impaired physical function, and compromised skin integrity of the residual limb. This study seeks to address chronic gait asymmetry by evaluating the efficacy of two error-manipulation gait training programs to improve gait symmetry for Veterans with non-traumatic lower limb amputation. Additional this study will evaluate the potential of error-manipulation training programs to improve secondary measures of disability and residual limb skin health. Ultimately, this study aims to improve conventional prosthetic rehabilitation for Veterans with non-traumatic amputation through gait training programs based in motor learning principles, resulting in improved gait symmetry and lower incidence of long-term disability after non-traumatic lower limb amputation.
|
{
"A": "Arm Label: Reference analgesic; Type: ACTIVE_COMPARATOR; Interventions: Drug: Gabapentin, Procedure: Rehabilitation, Other: Local care | Arm Label: reference analgesic and mirror therapy; Type: EXPERIMENTAL; Interventions: Procedure: Mirror Therapy, Drug: Gabapentin, Procedure: Rehabilitation, Other: Local care | Intervention Type: PROCEDURE; Name: Mirror Therapy; Assigned to Arm(s): reference analgesic and mirror therapy | Intervention Type: DRUG; Name: Gabapentin; Assigned to Arm(s): Reference analgesic, reference analgesic and mirror therapy | Intervention Type: PROCEDURE; Name: Rehabilitation; Assigned to Arm(s): Reference analgesic, reference analgesic and mirror therapy | Intervention Type: OTHER; Name: Local care; Assigned to Arm(s): Reference analgesic, reference analgesic and mirror therapy",
"B": "Arm Label: SMART & Peer Support; Type: EXPERIMENTAL; Interventions: Device: Self-Management for Amputee Rehabilitation using Technology [SMART] | Intervention Type: DEVICE; Name: Self-Management for Amputee Rehabilitation using Technology [SMART]; Assigned to Arm(s): SMART & Peer Support",
"C": "Arm Label: Error-augmentation training; Type: EXPERIMENTAL; Interventions: Behavioral: Error-augmentation gait training | Arm Label: Error-correction training; Type: EXPERIMENTAL; Interventions: Behavioral: Error-correction gait training | Arm Label: Supervised waking; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Supervised walking | Intervention Type: BEHAVIORAL; Name: Error-augmentation gait training; Assigned to Arm(s): Error-augmentation training | Intervention Type: BEHAVIORAL; Name: Error-correction gait training; Assigned to Arm(s): Error-correction training | Intervention Type: BEHAVIORAL; Name: Supervised walking; Assigned to Arm(s): Supervised waking",
"D": "Arm Label: Exercise, activity, and self-management; Type: EXPERIMENTAL; Interventions: Behavioral: Exercise, Behavioral: Walking Program, Behavioral: Health Self-Management Support | Arm Label: Home and phone visit; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Exercise; Assigned to Arm(s): Exercise, activity, and self-management | Intervention Type: BEHAVIORAL; Name: Walking Program; Assigned to Arm(s): Exercise, activity, and self-management | Intervention Type: BEHAVIORAL; Name: Health Self-Management Support; Assigned to Arm(s): Exercise, activity, and self-management"
}
|
C
|
[
"NCT03149432",
"NCT04120038",
"NCT03995238",
"NCT01929018"
] | 27,267 |
val
|
NCT03995264
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Ultrasound vs Palpation for Radial Artery Cannulation in Patients Undergoing Bariatic Surgery
Brief Summary: The primary purpose of this study is to compare the palpation technique with ultrasound guidance for radial artery cannulation for bariatic surgery.
|
{
"A": "Arm Label: Distal radial artery access; Type: EXPERIMENTAL; Interventions: Procedure: Distal radial artery access | Arm Label: Proximal radial artery access; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Proximal radial artery surgery | Intervention Type: PROCEDURE; Name: Distal radial artery access; Assigned to Arm(s): Distal radial artery access | Intervention Type: PROCEDURE; Name: Proximal radial artery surgery; Assigned to Arm(s): Proximal radial artery access",
"B": "Arm Label: Oblique; Type: EXPERIMENTAL; Interventions: Procedure: radial artery Catheterization | Arm Label: Transverse group; Type: ACTIVE_COMPARATOR; Interventions: Procedure: radial artery Catheterization | Arm Label: Longitudinal group; Type: ACTIVE_COMPARATOR; Interventions: Procedure: radial artery Catheterization | Intervention Type: PROCEDURE; Name: radial artery Catheterization; Assigned to Arm(s): Longitudinal group, Oblique, Transverse group",
"C": "Arm Label: Conventional method (CM); Type: ACTIVE_COMPARATOR; Interventions: Procedure: Radial artery cannulation | Arm Label: Ultrasound guided method (USG); Type: EXPERIMENTAL; Interventions: Procedure: Radial artery cannulation | Intervention Type: PROCEDURE; Name: Radial artery cannulation; Assigned to Arm(s): Conventional method (CM), Ultrasound guided method (USG)",
"D": "Arm Label: Ultrasound group; Type: EXPERIMENTAL; Interventions: Procedure: Ultrasound -guided cannulation | Arm Label: Palpation group; Type: PLACEBO_COMPARATOR; Interventions: Procedure: Palpation -guided cannulation | Intervention Type: PROCEDURE; Name: Ultrasound -guided cannulation; Assigned to Arm(s): Ultrasound group | Intervention Type: PROCEDURE; Name: Palpation -guided cannulation; Assigned to Arm(s): Palpation group"
}
|
D
|
[
"NCT04318990",
"NCT02550223",
"NCT02825615",
"NCT03995264"
] | 27,268 |
val
|
NCT03995264
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Ultrasound vs Palpation for Radial Artery Cannulation in Patients Undergoing Bariatic Surgery
Brief Summary: The primary purpose of this study is to compare the palpation technique with ultrasound guidance for radial artery cannulation for bariatic surgery.
|
{
"A": "Arm Label: Distal radial artery access; Type: EXPERIMENTAL; Interventions: Procedure: Distal radial artery access | Arm Label: Proximal radial artery access; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Proximal radial artery surgery | Intervention Type: PROCEDURE; Name: Distal radial artery access; Assigned to Arm(s): Distal radial artery access | Intervention Type: PROCEDURE; Name: Proximal radial artery surgery; Assigned to Arm(s): Proximal radial artery access",
"B": "Arm Label: The first group; Type: ACTIVE_COMPARATOR; Interventions: Procedure: The radial artery cannulation over 2 cm of the wrist | Arm Label: The second group; Type: EXPERIMENTAL; Interventions: Procedure: The radial artery cannulation in the distal 3/4 area of the forearm | Arm Label: The third group; Type: EXPERIMENTAL; Interventions: Procedure: The radial artery cannulation in the distal 1/2 area of the forearm | Intervention Type: PROCEDURE; Name: The radial artery cannulation over 2 cm of the wrist; Assigned to Arm(s): The first group | Intervention Type: PROCEDURE; Name: The radial artery cannulation in the distal 3/4 area of the forearm; Assigned to Arm(s): The second group | Intervention Type: PROCEDURE; Name: The radial artery cannulation in the distal 1/2 area of the forearm; Assigned to Arm(s): The third group",
"C": "Arm Label: Dynamic needle tip positioning; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Dynamic needle tip positioning under ultrasound-guidance | Arm Label: Conventional long-axis; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Conventional long-axis view | Intervention Type: PROCEDURE; Name: Dynamic needle tip positioning under ultrasound-guidance; Assigned to Arm(s): Dynamic needle tip positioning | Intervention Type: PROCEDURE; Name: Conventional long-axis view; Assigned to Arm(s): Conventional long-axis",
"D": "Arm Label: Ultrasound group; Type: EXPERIMENTAL; Interventions: Procedure: Ultrasound -guided cannulation | Arm Label: Palpation group; Type: PLACEBO_COMPARATOR; Interventions: Procedure: Palpation -guided cannulation | Intervention Type: PROCEDURE; Name: Ultrasound -guided cannulation; Assigned to Arm(s): Ultrasound group | Intervention Type: PROCEDURE; Name: Palpation -guided cannulation; Assigned to Arm(s): Palpation group"
}
|
D
|
[
"NCT04318990",
"NCT04001764",
"NCT03405623",
"NCT03995264"
] | 27,269 |
val
|
NCT03995264
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Ultrasound vs Palpation for Radial Artery Cannulation in Patients Undergoing Bariatic Surgery
Brief Summary: The primary purpose of this study is to compare the palpation technique with ultrasound guidance for radial artery cannulation for bariatic surgery.
|
{
"A": "Arm Label: Infant; Type: EXPERIMENTAL; Interventions: Other: Long-axis/in-plane US-guided arterial catheterization, Other: Short-axis/out-of-plane US-guided arterial catheterization | Arm Label: Preschool child; Type: EXPERIMENTAL; Interventions: Other: Long-axis/in-plane US-guided arterial catheterization, Other: Short-axis/out-of-plane US-guided arterial catheterization | Intervention Type: OTHER; Name: Long-axis/in-plane US-guided arterial catheterization; Assigned to Arm(s): Infant, Preschool child | Intervention Type: OTHER; Name: Short-axis/out-of-plane US-guided arterial catheterization; Assigned to Arm(s): Infant, Preschool child",
"B": "Arm Label: Palpation; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Palpation | Arm Label: Ultrasound; Type: EXPERIMENTAL; Interventions: Procedure: Ultrasound guidance | Intervention Type: PROCEDURE; Name: Ultrasound guidance; Assigned to Arm(s): Ultrasound | Intervention Type: PROCEDURE; Name: Palpation; Assigned to Arm(s): Palpation",
"C": "Arm Label: direct palpation; Type: ACTIVE_COMPARATOR; Interventions: Device: Direct Palpation-guided Radial Artery Catheter insertion | Arm Label: Ultrasound; Type: ACTIVE_COMPARATOR; Interventions: Device: Ultrasound-guided Radial Artery Catheter Insertion | Intervention Type: DEVICE; Name: Ultrasound-guided Radial Artery Catheter Insertion; Assigned to Arm(s): Ultrasound | Intervention Type: DEVICE; Name: Direct Palpation-guided Radial Artery Catheter insertion; Assigned to Arm(s): direct palpation",
"D": "Arm Label: Ultrasound group; Type: EXPERIMENTAL; Interventions: Procedure: Ultrasound -guided cannulation | Arm Label: Palpation group; Type: PLACEBO_COMPARATOR; Interventions: Procedure: Palpation -guided cannulation | Intervention Type: PROCEDURE; Name: Ultrasound -guided cannulation; Assigned to Arm(s): Ultrasound group | Intervention Type: PROCEDURE; Name: Palpation -guided cannulation; Assigned to Arm(s): Palpation group"
}
|
D
|
[
"NCT02333786",
"NCT01605292",
"NCT02118441",
"NCT03995264"
] | 27,270 |
val
|
NCT03996057
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Efficacy and Effect of Methenamine Hippurate in a Non-antibiotic, Multimodal Approach to UTI Prevention
Brief Summary: Urinary tract infections (UTIs) are the most common bacterial infection and are especially common in postmenopausal women, who often experience recurrent UTIs. Women with recurrent UTIs are commonly treated with antibiotics, but side effects, collateral damage to commensal bacteria, and antimicrobial resistance result from frequent antibiotic use. It is paramount that researchers develop non-antibiotic treatment strategies for UTIs.
Several non-antibiotic strategies may be successful in preventing recurrent UTIs in postmenopausal women, including low-dose vaginal estrogen, d-mannose, and methenamine hippurate. Methenamine hippurate (MH) is interesting as it causes few side effects, kills bacteria by denaturing bacterial proteins, RNA, and DNA, and does not develop resistance. Several studies have demonstrated the efficacy of daily methenamine on the incidence of UTI. However, women often require multiple therapies in order to prevent recurrence. There are currently few guidelines to help clinicians identify optimal treatment regimens for non-antibiotic prevention of UTI.
The purpose of this pilot study is to examine the feasibility of developing a sequential, multiple assignment, randomization trial (SMART); and examine the treatment effect of MH in combination with vaginal estrogen (VET) and D-mannose on prevention of UTI. The investigators plan to examine the efficacy of the addition of MH to low dose VET and d-mannose in the UTI prevention through randomization to MH + VET + D-mannose vs continuing VET + D-mannose alone. The primary outcome will be the proportion of patients who have symptomatic, culture-proven UTI during a 3 month treatment period. The investigators hypothesize that women on low dose VET, d-mannose, and MH will be less likely to have recurrent UTI than those with VET and d-mannose alone.
This study uses a pragmatic, longitudinal approach that mimics patients' clinical experiences and physicians' decision points during management of UTI prophylaxis. Through this randomized, controlled pilot study, this proposal would allow the investigators to examine the feasibility of conducting a larger-scale, adaptive study trial, and estimate the treatment effect of a non-antibiotic regimen augmented with MH in women who continue to develop recurrence.
|
{
"A": "Arm Label: mannose; Type: EXPERIMENTAL; Interventions: Drug: Mannose | Arm Label: placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Lactose | Intervention Type: DRUG; Name: Mannose; Assigned to Arm(s): mannose | Intervention Type: DRUG; Name: Lactose; Assigned to Arm(s): placebo",
"B": "Arm Label: D Mannose; Type: EXPERIMENTAL; Interventions: Dietary Supplement: D Mannose, Drug: trimethoprim/sulfamethoxazole | Arm Label: trimethoprim/sulfamethoxazole; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: D Mannose, Drug: trimethoprim/sulfamethoxazole | Intervention Type: DIETARY_SUPPLEMENT; Name: D Mannose; Assigned to Arm(s): D Mannose, trimethoprim/sulfamethoxazole | Intervention Type: DRUG; Name: trimethoprim/sulfamethoxazole; Assigned to Arm(s): D Mannose, trimethoprim/sulfamethoxazole",
"C": "Arm Label: Treatment; Type: EXPERIMENTAL; Interventions: Dietary Supplement: WelTract | Arm Label: Control; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: WelTract; Assigned to Arm(s): Treatment | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo; Assigned to Arm(s): Control",
"D": "Arm Label: Methenamine augmentation; Type: EXPERIMENTAL; Interventions: Drug: Methenamine Hippurate 1000 MG, Drug: Vaginal estrogen, Dietary Supplement: D-mannose | Arm Label: No methenamine augmentation; Type: ACTIVE_COMPARATOR; Interventions: Drug: Vaginal estrogen, Dietary Supplement: D-mannose | Intervention Type: DRUG; Name: Methenamine Hippurate 1000 MG; Assigned to Arm(s): Methenamine augmentation | Intervention Type: DRUG; Name: Vaginal estrogen; Assigned to Arm(s): Methenamine augmentation, No methenamine augmentation | Intervention Type: DIETARY_SUPPLEMENT; Name: D-mannose; Assigned to Arm(s): Methenamine augmentation, No methenamine augmentation"
}
|
D
|
[
"NCT03497598",
"NCT01808755",
"NCT03597152",
"NCT03996057"
] | 27,271 |
val
|
NCT03996772
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: PREvention of STroke in Intracerebral haemorrhaGE Survivors With Atrial Fibrillation (PRESTIGE-AF)
Brief Summary: Atrial fibrillation (AF) is the most common form of irregular heart rhythm. In people with AF, blood clots often form in the heart, which can travel to the brain. Blockage of brain arteries by these clots is a major cause of stroke. This type of stroke is called an ischaemic stroke and approximately 15% of all ischaemic strokes are caused by AF.
People with AF are often prescribed a medication called an anticoagulant, which makes it less likely for blood clots to form and thus can prevent ischaemic strokes. However, anticoagulants also increase the risk of bleeding, so they are not suitable for everyone.
Some people who have AF have had a different type of stroke which is caused by bleeding in the brain, an intracerebral haemorrhage (ICH). These people are at increased risk of suffering both an ischaemic stroke (due to AF) and another ICH. It is not known whether it is best for these people to take an anticoagulant medication or not, as previous research studies did not include this group of people.
PREvention of STroke in Intracerebral haemorrhaGE survivors with Atrial Fibrillation (PRESTIGE-AF) is a research study on the best stroke prevention in people with atrial fibrillation (AF) who have recently had a bleeding in their brain, (ICH). This is a trial where half of the participants will take an anticoagulant medication, preventing blood clot formation, and half will not receive an anticoagulant. The direct oral anticoagulants (DOACs) that will be used in this trial are all licenced for use in the United Kingdom and within the European Union (EU) to prevent strokes in people with AF. However, the current licence does not extend to use with people who have had an ICH because it has not been tested in this group with a randomised controlled trial. DOACs will be tested in ICH survivors with AF because previous research trials have shown that people are up to 50% less likely to have bleeding complications in the brain with DOACs than with Warfarin (another commonly used anticoagulant).
The aim of PRESTIGE-AF is to answer the question of whether people with ICH and AF should take an anticoagulant medication or if it is better for them to avoid it.
|
{
"A": "Arm Label: low weight molecular heparin; Type: EXPERIMENTAL; Interventions: Drug: Enoxaparin | Arm Label: standard therapy; Type: PLACEBO_COMPARATOR; Interventions: Other: Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization | Intervention Type: DRUG; Name: Enoxaparin; Assigned to Arm(s): low weight molecular heparin | Intervention Type: OTHER; Name: Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization; Assigned to Arm(s): standard therapy",
"B": "Arm Label: Direct Oral Anticoagulant; Type: EXPERIMENTAL; Interventions: Drug: Apixaban Oral Tablet, Drug: Dabigatran, Drug: Edoxaban Tablets, Drug: Rivaroxaban | Arm Label: No Anticoagulant; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: Apixaban Oral Tablet; Assigned to Arm(s): Direct Oral Anticoagulant | Intervention Type: DRUG; Name: Dabigatran; Assigned to Arm(s): Direct Oral Anticoagulant | Intervention Type: DRUG; Name: Edoxaban Tablets; Assigned to Arm(s): Direct Oral Anticoagulant | Intervention Type: DRUG; Name: Rivaroxaban; Assigned to Arm(s): Direct Oral Anticoagulant",
"C": "Arm Label: DU-176b 15 mg group; Type: EXPERIMENTAL; Interventions: Drug: Du-176b | Arm Label: Placebo group; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: Du-176b; Assigned to Arm(s): DU-176b 15 mg group | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Placebo group",
"D": "Arm Label: Antithrombotic treatment; Type: EXPERIMENTAL; Interventions: Drug: Antithrombotic Agent | Arm Label: No antithrombotic treatment; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: Antithrombotic Agent; Assigned to Arm(s): Antithrombotic treatment"
}
|
B
|
[
"NCT01573169",
"NCT03996772",
"NCT02801669",
"NCT03186729"
] | 27,272 |
val
|
NCT03997513
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Impact of a Home-based Pulmonary Telerehabilitation Program on Muscle Function and Quality of Life Following Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Brief Summary: COPD impacts a significant proportion of the Veteran population. Acute exacerbations, or flare-ups, of COPD are associated with impaired muscle function and worse quality of life. Pulmonary rehabilitation, a formal exercise program for patients with lung disease that includes both endurance and strength training exercises, has been shown to improve muscle function and quality of life after an acute exacerbation of COPD. However, lack of geographically accessible rehabilitation facilities and/or transportation issues are often barriers to pulmonary rehabilitation attendance in the Veteran population. This study will assess the feasibility and impact of an eight-week, three sessions per week, home-based, pulmonary telerehabilitation program in Veterans with COPD following hospitalization for an acute exacerbation of their lung disease. We will measure adherence and satisfaction with the program and muscle strength, physical activity, quality of life, and exercise tolerance pre and post-intervention in Veterans randomized to the pulmonary telerehabilitation arm versus Veterans randomized to the control arm who do not participate in pulmonary rehabilitation.
|
{
"A": "Arm Label: Pulmonary Telerehabilitation Intervention Group; Type: EXPERIMENTAL; Interventions: Behavioral: Pulmonary Telerehabilitation | Arm Label: Usual Care Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Pulmonary Telerehabilitation; Assigned to Arm(s): Pulmonary Telerehabilitation Intervention Group",
"B": "Arm Label: Face to Face Pulmonary Rehabilitaton; Type: OTHER; Interventions: Behavioral: Face to Face Pulmonary Rehabilitaton | Arm Label: Online Pulmonary Rehabilitation; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Online Pulmonary Rehab | Intervention Type: BEHAVIORAL; Name: Face to Face Pulmonary Rehabilitaton; Assigned to Arm(s): Face to Face Pulmonary Rehabilitaton | Intervention Type: BEHAVIORAL; Name: Online Pulmonary Rehab; Assigned to Arm(s): Online Pulmonary Rehabilitation",
"C": "Arm Label: Tool + Self-management Support Program; Type: EXPERIMENTAL; Interventions: Device: Tool, Behavioral: Self-management Support Program | Arm Label: Self- management Support Program; Type: EXPERIMENTAL; Interventions: Behavioral: Self-management Support Program | Arm Label: Care as usual; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Tool; Assigned to Arm(s): Tool + Self-management Support Program | Intervention Type: BEHAVIORAL; Name: Self-management Support Program; Assigned to Arm(s): Self- management Support Program, Tool + Self-management Support Program",
"D": "Arm Label: Intervention group; Type: EXPERIMENTAL; Interventions: Other: Web Platform | Intervention Type: OTHER; Name: Web Platform; Assigned to Arm(s): Intervention group"
}
|
A
|
[
"NCT03997513",
"NCT02706613",
"NCT01867970",
"NCT04284865"
] | 27,273 |
val
|
NCT03997513
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Impact of a Home-based Pulmonary Telerehabilitation Program on Muscle Function and Quality of Life Following Acute Exacerbations of Chronic Obstructive Pulmonary Disease
Brief Summary: COPD impacts a significant proportion of the Veteran population. Acute exacerbations, or flare-ups, of COPD are associated with impaired muscle function and worse quality of life. Pulmonary rehabilitation, a formal exercise program for patients with lung disease that includes both endurance and strength training exercises, has been shown to improve muscle function and quality of life after an acute exacerbation of COPD. However, lack of geographically accessible rehabilitation facilities and/or transportation issues are often barriers to pulmonary rehabilitation attendance in the Veteran population. This study will assess the feasibility and impact of an eight-week, three sessions per week, home-based, pulmonary telerehabilitation program in Veterans with COPD following hospitalization for an acute exacerbation of their lung disease. We will measure adherence and satisfaction with the program and muscle strength, physical activity, quality of life, and exercise tolerance pre and post-intervention in Veterans randomized to the pulmonary telerehabilitation arm versus Veterans randomized to the control arm who do not participate in pulmonary rehabilitation.
|
{
"A": "Arm Label: Activity-Self Management; Type: EXPERIMENTAL; Interventions: Behavioral: Self-Management and Motivational Interviewing | Arm Label: Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Self-Management and Motivational Interviewing; Assigned to Arm(s): Activity-Self Management",
"B": "Arm Label: Pulmonary Telerehabilitation Intervention Group; Type: EXPERIMENTAL; Interventions: Behavioral: Pulmonary Telerehabilitation | Arm Label: Usual Care Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Pulmonary Telerehabilitation; Assigned to Arm(s): Pulmonary Telerehabilitation Intervention Group",
"C": "Arm Label: MI + IVR; Type: EXPERIMENTAL; Interventions: Behavioral: MI + IVR | Arm Label: Usual Care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: MI + IVR; Assigned to Arm(s): MI + IVR",
"D": "Arm Label: Intervention group \"tele-rehabilitation\"; Type: EXPERIMENTAL; Interventions: Behavioral: Virtual Autonomous Physiotherapist Agent (VAPA) | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Virtual Autonomous Physiotherapist Agent (VAPA) | Intervention Type: BEHAVIORAL; Name: Virtual Autonomous Physiotherapist Agent (VAPA); Assigned to Arm(s): Control, Intervention group \"tele-rehabilitation\""
}
|
B
|
[
"NCT01058486",
"NCT03997513",
"NCT01855022",
"NCT03548181"
] | 27,274 |
val
|
NCT03997864
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Administration of Prazosin to Prevent PTSD After Sexual Assault
Brief Summary: This study plans to learn more about whether taking the medication, Prazosin, immediately and during the weeks immediately following a traumatic event can help to reduce the risk of developing posttraumatic stress disorder (PTSD). Early post traumatic event sleep disturbance predicts the later development of PTSD. Prazosin has shown some effectiveness in reducing trauma related nightmares and sleep disturbance. We hypothesize that regulating sleep immediately after a sexual assault will reduce PTSD and diminish symptoms.
|
{
"A": "Arm Label: ALEOZEN group; Type: EXPERIMENTAL; Interventions: Drug: aleozen | Arm Label: placebo group; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo Oral Tablet | Intervention Type: DRUG; Name: aleozen; Assigned to Arm(s): ALEOZEN group | Intervention Type: DRUG; Name: Placebo Oral Tablet; Assigned to Arm(s): placebo group",
"B": "Arm Label: Treatment - prazosin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Prazosin | Arm Label: Control - placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebos | Intervention Type: DRUG; Name: Prazosin; Assigned to Arm(s): Treatment - prazosin | Intervention Type: DRUG; Name: Placebos; Assigned to Arm(s): Control - placebo",
"C": "Arm Label: Ketamine; Type: ACTIVE_COMPARATOR; Interventions: Drug: Ketamine Hydrochloride | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo-Comparator | Intervention Type: DRUG; Name: Ketamine Hydrochloride; Assigned to Arm(s): Ketamine | Intervention Type: DRUG; Name: Placebo-Comparator; Assigned to Arm(s): Placebo",
"D": "Arm Label: Hydrocortisone injection; Type: ACTIVE_COMPARATOR; Interventions: Drug: Hydrocortisone | Arm Label: normal saline; Type: PLACEBO_COMPARATOR; Interventions: Drug: normal saline 0.9% | Intervention Type: DRUG; Name: Hydrocortisone; Assigned to Arm(s): Hydrocortisone injection | Intervention Type: DRUG; Name: normal saline 0.9%; Assigned to Arm(s): normal saline"
}
|
B
|
[
"NCT03724448",
"NCT03997864",
"NCT02866071",
"NCT02090309"
] | 27,275 |
val
|
NCT04001036
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Efficacy and Safety Assessments of a Peritoneal Dialysis Solution Containing Glucose, Xylitol and L-Carnitine Compared to Standard PD Solutions in Continuous Ambulatory Peritoneal Dialysis (CAPD)
Brief Summary: Prospective, randomized, controlled clinical trial. The aim is to compare the effects of the peritoneal dialysis solution IPX15, containing glucose (0.5%), xylitol (1.5%) and L-carnitine (0.02%) as osmotic agents (comparable to the standard 2.5% glucose PD solution), for the nocturnal exchange with the PD solution IPX07, containing glucose (0.5%), xylitol (0.7%) and L-carnitine (0.02%) as osmotic agents (comparable to the standard 1.5% glucose PD solution), for the diurnal (short dwell) exchanges. Planned total recruitment is 40 patients with stable end-stage renal disease (ESRD) treated by continuous ambulatory peritoneal dialysis (CAPD). Treatment duration will be 4 weeks plus a 4 weeks safety follow up with no treatment.
|
{
"A": "Arm Label: Experimental peritoneal dialysis solution IPX15; Type: EXPERIMENTAL; Interventions: Drug: 1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitine | Arm Label: Experimental peritoneal dialysis solution IPX07; Type: EXPERIMENTAL; Interventions: Drug: 0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitine | Intervention Type: DRUG; Name: 1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitine; Assigned to Arm(s): Experimental peritoneal dialysis solution IPX15 | Intervention Type: DRUG; Name: 0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitine; Assigned to Arm(s): Experimental peritoneal dialysis solution IPX07",
"B": "Arm Label: Oral nutritional supplement with probiotics; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Oral nutritional supplement with probiotics | Arm Label: Oral nutritional supplement without probiotics; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Oral nutritional supplement without probiotics | Arm Label: Individualized dietary recommendations; Type: ACTIVE_COMPARATOR; Interventions: Other: Dietary recommendations | Intervention Type: DIETARY_SUPPLEMENT; Name: Oral nutritional supplement with probiotics; Assigned to Arm(s): Oral nutritional supplement with probiotics | Intervention Type: DIETARY_SUPPLEMENT; Name: Oral nutritional supplement without probiotics; Assigned to Arm(s): Oral nutritional supplement without probiotics | Intervention Type: OTHER; Name: Dietary recommendations; Assigned to Arm(s): Individualized dietary recommendations",
"C": "Arm Label: placebo; Type: OTHER; Interventions: Drug: placebo | Arm Label: L-carnitine; Type: OTHER; Interventions: Drug: L-carnitine | Intervention Type: DRUG; Name: L-carnitine; Assigned to Arm(s): L-carnitine | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): placebo",
"D": "Arm Label: UCR; Type: ACTIVE_COMPARATOR; Interventions: Device: UCR | Arm Label: UTR; Type: ACTIVE_COMPARATOR; Interventions: Device: UTR | Arm Label: conventional dialysis; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: UCR; Assigned to Arm(s): UCR | Intervention Type: DEVICE; Name: UTR; Assigned to Arm(s): UTR"
}
|
A
|
[
"NCT04001036",
"NCT03924089",
"NCT01278693",
"NCT01416753"
] | 27,276 |
val
|
NCT04001764
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Comparison of the Efficacy of Radial Artery Catheterization in Three Different Regions in Intensive Care Patients
Brief Summary: In this prospective, randomized, open-labeled study, the intensive care patients will be selected for ultrasound-guided cannulation of the radial artery in three different regions. Patients will be divided into three groups with simple randomization. The first group will be determined as 'G1' and the radial artery catheterization with ultrasound-guided short axis out of plane intervention will be performed over 2 cm of the wrist for this group. On the second group (G2), radial artery catheterization will be performed in the distal 3/4 area of the forearm with ultrasound-guided short axis out of plane intervention. On the third group (G3), radial arterial catheterization will be performed in the distal 1/2 area of the forearm with ultrasound-guided short axis out of plane interference. Whether there is a difference in the duration of use of arterial cannula, first entry success rates, duration of intervention, number of procedures, the number of cannulas used and the effects on early and late complications and advantages between the groups will be investigated.
|
{
"A": "Arm Label: Conventional method (CM); Type: ACTIVE_COMPARATOR; Interventions: Procedure: Radial artery cannulation | Arm Label: Ultrasound guided method (USG); Type: EXPERIMENTAL; Interventions: Procedure: Radial artery cannulation | Intervention Type: PROCEDURE; Name: Radial artery cannulation; Assigned to Arm(s): Conventional method (CM), Ultrasound guided method (USG)",
"B": "Arm Label: The first group; Type: ACTIVE_COMPARATOR; Interventions: Procedure: The radial artery cannulation over 2 cm of the wrist | Arm Label: The second group; Type: EXPERIMENTAL; Interventions: Procedure: The radial artery cannulation in the distal 3/4 area of the forearm | Arm Label: The third group; Type: EXPERIMENTAL; Interventions: Procedure: The radial artery cannulation in the distal 1/2 area of the forearm | Intervention Type: PROCEDURE; Name: The radial artery cannulation over 2 cm of the wrist; Assigned to Arm(s): The first group | Intervention Type: PROCEDURE; Name: The radial artery cannulation in the distal 3/4 area of the forearm; Assigned to Arm(s): The second group | Intervention Type: PROCEDURE; Name: The radial artery cannulation in the distal 1/2 area of the forearm; Assigned to Arm(s): The third group",
"C": "Arm Label: Fluoroscopic + Ultrasound Guidance; Type: EXPERIMENTAL; Interventions: Procedure: Fluoroscopic + Ultrasound Guidance | Arm Label: Fluoroscopic Guidance Alone; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: PROCEDURE; Name: Fluoroscopic + Ultrasound Guidance; Assigned to Arm(s): Fluoroscopic + Ultrasound Guidance",
"D": "Arm Label: Palpation; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Palpation | Arm Label: Ultrasound; Type: EXPERIMENTAL; Interventions: Procedure: Ultrasound guidance | Intervention Type: PROCEDURE; Name: Ultrasound guidance; Assigned to Arm(s): Ultrasound | Intervention Type: PROCEDURE; Name: Palpation; Assigned to Arm(s): Palpation"
}
|
B
|
[
"NCT02825615",
"NCT04001764",
"NCT03537118",
"NCT01605292"
] | 27,277 |
val
|
NCT04001764
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Comparison of the Efficacy of Radial Artery Catheterization in Three Different Regions in Intensive Care Patients
Brief Summary: In this prospective, randomized, open-labeled study, the intensive care patients will be selected for ultrasound-guided cannulation of the radial artery in three different regions. Patients will be divided into three groups with simple randomization. The first group will be determined as 'G1' and the radial artery catheterization with ultrasound-guided short axis out of plane intervention will be performed over 2 cm of the wrist for this group. On the second group (G2), radial artery catheterization will be performed in the distal 3/4 area of the forearm with ultrasound-guided short axis out of plane intervention. On the third group (G3), radial arterial catheterization will be performed in the distal 1/2 area of the forearm with ultrasound-guided short axis out of plane interference. Whether there is a difference in the duration of use of arterial cannula, first entry success rates, duration of intervention, number of procedures, the number of cannulas used and the effects on early and late complications and advantages between the groups will be investigated.
|
{
"A": "Arm Label: CAIG; Type: EXPERIMENTAL; Interventions: Device: Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities. | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.; Assigned to Arm(s): CAIG",
"B": "Arm Label: Palpation only; Type: ACTIVE_COMPARATOR; Interventions: Procedure: RAP palpation only | Arm Label: Ultrasound guidance; Type: EXPERIMENTAL; Interventions: Procedure: RAP with ultrasound guidance | Intervention Type: PROCEDURE; Name: RAP palpation only; Assigned to Arm(s): Palpation only | Intervention Type: PROCEDURE; Name: RAP with ultrasound guidance; Assigned to Arm(s): Ultrasound guidance",
"C": "Arm Label: The first group; Type: ACTIVE_COMPARATOR; Interventions: Procedure: The radial artery cannulation over 2 cm of the wrist | Arm Label: The second group; Type: EXPERIMENTAL; Interventions: Procedure: The radial artery cannulation in the distal 3/4 area of the forearm | Arm Label: The third group; Type: EXPERIMENTAL; Interventions: Procedure: The radial artery cannulation in the distal 1/2 area of the forearm | Intervention Type: PROCEDURE; Name: The radial artery cannulation over 2 cm of the wrist; Assigned to Arm(s): The first group | Intervention Type: PROCEDURE; Name: The radial artery cannulation in the distal 3/4 area of the forearm; Assigned to Arm(s): The second group | Intervention Type: PROCEDURE; Name: The radial artery cannulation in the distal 1/2 area of the forearm; Assigned to Arm(s): The third group",
"D": "Arm Label: direct palpation; Type: ACTIVE_COMPARATOR; Interventions: Device: Direct Palpation-guided Radial Artery Catheter insertion | Arm Label: Ultrasound; Type: ACTIVE_COMPARATOR; Interventions: Device: Ultrasound-guided Radial Artery Catheter Insertion | Intervention Type: DEVICE; Name: Ultrasound-guided Radial Artery Catheter Insertion; Assigned to Arm(s): Ultrasound | Intervention Type: DEVICE; Name: Direct Palpation-guided Radial Artery Catheter insertion; Assigned to Arm(s): direct palpation"
}
|
C
|
[
"NCT02584673",
"NCT01789801",
"NCT04001764",
"NCT02118441"
] | 27,278 |
val
|
NCT04001764
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Comparison of the Efficacy of Radial Artery Catheterization in Three Different Regions in Intensive Care Patients
Brief Summary: In this prospective, randomized, open-labeled study, the intensive care patients will be selected for ultrasound-guided cannulation of the radial artery in three different regions. Patients will be divided into three groups with simple randomization. The first group will be determined as 'G1' and the radial artery catheterization with ultrasound-guided short axis out of plane intervention will be performed over 2 cm of the wrist for this group. On the second group (G2), radial artery catheterization will be performed in the distal 3/4 area of the forearm with ultrasound-guided short axis out of plane intervention. On the third group (G3), radial arterial catheterization will be performed in the distal 1/2 area of the forearm with ultrasound-guided short axis out of plane interference. Whether there is a difference in the duration of use of arterial cannula, first entry success rates, duration of intervention, number of procedures, the number of cannulas used and the effects on early and late complications and advantages between the groups will be investigated.
|
{
"A": "Arm Label: Ultrasound group; Type: EXPERIMENTAL; Interventions: Procedure: Ultrasound -guided cannulation | Arm Label: Palpation group; Type: PLACEBO_COMPARATOR; Interventions: Procedure: Palpation -guided cannulation | Intervention Type: PROCEDURE; Name: Ultrasound -guided cannulation; Assigned to Arm(s): Ultrasound group | Intervention Type: PROCEDURE; Name: Palpation -guided cannulation; Assigned to Arm(s): Palpation group",
"B": "Arm Label: Dynamic; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: dynamic | Arm Label: Regular-triangle; Type: PLACEBO_COMPARATOR; Interventions: Behavioral: Regular-triangle | Intervention Type: BEHAVIORAL; Name: dynamic; Assigned to Arm(s): Dynamic | Intervention Type: BEHAVIORAL; Name: Regular-triangle; Assigned to Arm(s): Regular-triangle",
"C": "Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Ultrasound; Type: EXPERIMENTAL; Interventions: Device: Real-time Ultrasound Guidance (Site-Rite 5 or 6 machine) | Intervention Type: DEVICE; Name: Real-time Ultrasound Guidance (Site-Rite 5 or 6 machine); Assigned to Arm(s): Ultrasound",
"D": "Arm Label: The first group; Type: ACTIVE_COMPARATOR; Interventions: Procedure: The radial artery cannulation over 2 cm of the wrist | Arm Label: The second group; Type: EXPERIMENTAL; Interventions: Procedure: The radial artery cannulation in the distal 3/4 area of the forearm | Arm Label: The third group; Type: EXPERIMENTAL; Interventions: Procedure: The radial artery cannulation in the distal 1/2 area of the forearm | Intervention Type: PROCEDURE; Name: The radial artery cannulation over 2 cm of the wrist; Assigned to Arm(s): The first group | Intervention Type: PROCEDURE; Name: The radial artery cannulation in the distal 3/4 area of the forearm; Assigned to Arm(s): The second group | Intervention Type: PROCEDURE; Name: The radial artery cannulation in the distal 1/2 area of the forearm; Assigned to Arm(s): The third group"
}
|
D
|
[
"NCT03995264",
"NCT03656978",
"NCT00667381",
"NCT04001764"
] | 27,279 |
val
|
NCT04002401
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 2 Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma (ZUMA-14)
Brief Summary: The primary objective of this study is to estimate the efficacy of axicabtagene ciloleucel in combination with rituximab, as measured by assessment of response rates in adult participants with relapsed/refractory large B-cell lymphoma.
|
{
"A": "Arm Label: Axicabtagene Ciloleucel and Rituximab Combination; Type: EXPERIMENTAL; Interventions: Biological: Axicabtagene Ciloleucel, Drug: Rituximab, Drug: Fludarabine, Drug: Cyclophosphamide | Intervention Type: BIOLOGICAL; Name: Axicabtagene Ciloleucel; Assigned to Arm(s): Axicabtagene Ciloleucel and Rituximab Combination | Intervention Type: DRUG; Name: Rituximab; Assigned to Arm(s): Axicabtagene Ciloleucel and Rituximab Combination | Intervention Type: DRUG; Name: Fludarabine; Assigned to Arm(s): Axicabtagene Ciloleucel and Rituximab Combination | Intervention Type: DRUG; Name: Cyclophosphamide; Assigned to Arm(s): Axicabtagene Ciloleucel and Rituximab Combination",
"B": "Arm Label: Treatment (T cell therapy); Type: EXPERIMENTAL; Interventions: Biological: allogeneic cytomegalovirus-specific cytotoxic T lymphocytes | Intervention Type: BIOLOGICAL; Name: allogeneic cytomegalovirus-specific cytotoxic T lymphocytes; Assigned to Arm(s): Treatment (T cell therapy)",
"C": "Arm Label: Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy; Type: EXPERIMENTAL; Interventions: Biological: Axicabtagene Ciloleucel, Drug: Fludarabine, Drug: Cyclophosphamide | Arm Label: Phase 2 (Pivotal Study): Cohort 1; Type: EXPERIMENTAL; Interventions: Biological: Axicabtagene Ciloleucel, Drug: Fludarabine, Drug: Cyclophosphamide | Arm Label: Phase 2 (Pivotal Study): Cohort 2; Type: EXPERIMENTAL; Interventions: Biological: Axicabtagene Ciloleucel, Drug: Fludarabine, Drug: Cyclophosphamide | Arm Label: Phase 2 (Safety Management Study): Cohort 3; Type: EXPERIMENTAL; Interventions: Biological: Axicabtagene Ciloleucel, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: Levetiracetam, Drug: Tocilizumab | Arm Label: Phase 2 (Safety Management Study): Cohort 4; Type: EXPERIMENTAL; Interventions: Biological: Axicabtagene Ciloleucel, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: Levetiracetam, Drug: Tocilizumab, Drug: Dexamethasone, Drug: High-dose methylprednisolone, Drug: Bendamustine, Drug: Rituximab | Arm Label: Phase 2 (Safety Management Study): Cohort 5; Type: EXPERIMENTAL; Interventions: Biological: Axicabtagene Ciloleucel, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: Levetiracetam, Drug: Rituximab, Drug: Doxorubicin, Drug: Prednisone, Drug: Vincristine, Drug: Ifosfamide, Drug: Carboplatin, Drug: Etoposide, Drug: Gemcitabine, Drug: Oxaliplatin, Drug: Cisplatin | Arm Label: Phase 2 (Safety Management Study): Cohort 6; Type: EXPERIMENTAL; Interventions: Biological: Axicabtagene Ciloleucel, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: Levetiracetam, Drug: Tocilizumab, Drug: Dexamethasone, Drug: High-dose methylprednisolone, Drug: Bendamustine, Drug: Rituximab, Drug: Methylprednisolone | Intervention Type: BIOLOGICAL; Name: Axicabtagene Ciloleucel; Assigned to Arm(s): Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy, Phase 2 (Pivotal Study): Cohort 1, Phase 2 (Pivotal Study): Cohort 2, Phase 2 (Safety Management Study): Cohort 3, Phase 2 (Safety Management Study): Cohort 4, Phase 2 (Safety Management Study): Cohort 5, Phase 2 (Safety Management Study): Cohort 6 | Intervention Type: DRUG; Name: Fludarabine; Assigned to Arm(s): Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy, Phase 2 (Pivotal Study): Cohort 1, Phase 2 (Pivotal Study): Cohort 2, Phase 2 (Safety Management Study): Cohort 3, Phase 2 (Safety Management Study): Cohort 4, Phase 2 (Safety Management Study): Cohort 5, Phase 2 (Safety Management Study): Cohort 6 | Intervention Type: DRUG; Name: Cyclophosphamide; Assigned to Arm(s): Phase 1 Study: Axicabtagene Ciloleucel and Conditioning Chemotherapy, Phase 2 (Pivotal Study): Cohort 1, Phase 2 (Pivotal Study): Cohort 2, Phase 2 (Safety Management Study): Cohort 3, Phase 2 (Safety Management Study): Cohort 4, Phase 2 (Safety Management Study): Cohort 5, Phase 2 (Safety Management Study): Cohort 6 | Intervention Type: DRUG; Name: Levetiracetam; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 3, Phase 2 (Safety Management Study): Cohort 4, Phase 2 (Safety Management Study): Cohort 5, Phase 2 (Safety Management Study): Cohort 6 | Intervention Type: DRUG; Name: Tocilizumab; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 3, Phase 2 (Safety Management Study): Cohort 4, Phase 2 (Safety Management Study): Cohort 6 | Intervention Type: DRUG; Name: Dexamethasone; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 4, Phase 2 (Safety Management Study): Cohort 6 | Intervention Type: DRUG; Name: High-dose methylprednisolone; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 4, Phase 2 (Safety Management Study): Cohort 6 | Intervention Type: DRUG; Name: Bendamustine; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 4, Phase 2 (Safety Management Study): Cohort 6 | Intervention Type: DRUG; Name: Rituximab; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 4, Phase 2 (Safety Management Study): Cohort 5, Phase 2 (Safety Management Study): Cohort 6 | Intervention Type: DRUG; Name: Doxorubicin; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 5 | Intervention Type: DRUG; Name: Prednisone; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 5 | Intervention Type: DRUG; Name: Vincristine; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 5 | Intervention Type: DRUG; Name: Ifosfamide; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 5 | Intervention Type: DRUG; Name: Carboplatin; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 5 | Intervention Type: DRUG; Name: Etoposide; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 5 | Intervention Type: DRUG; Name: Gemcitabine; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 5 | Intervention Type: DRUG; Name: Oxaliplatin; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 5 | Intervention Type: DRUG; Name: Cisplatin; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 5 | Intervention Type: DRUG; Name: Methylprednisolone; Assigned to Arm(s): Phase 2 (Safety Management Study): Cohort 6",
"D": "Arm Label: Treatment (fludarabine, cyclophosphamide, CD19 T cell); Type: EXPERIMENTAL; Interventions: Biological: Autologous CD19-CD8-CD28-CD3zeta-CAR-mbIL15-HER1t T Cells, Drug: Cyclophosphamide, Drug: Fludarabine | Intervention Type: BIOLOGICAL; Name: Autologous CD19-CD8-CD28-CD3zeta-CAR-mbIL15-HER1t T Cells; Assigned to Arm(s): Treatment (fludarabine, cyclophosphamide, CD19 T cell) | Intervention Type: DRUG; Name: Cyclophosphamide; Assigned to Arm(s): Treatment (fludarabine, cyclophosphamide, CD19 T cell) | Intervention Type: DRUG; Name: Fludarabine; Assigned to Arm(s): Treatment (fludarabine, cyclophosphamide, CD19 T cell)"
}
|
A
|
[
"NCT04002401",
"NCT01475058",
"NCT02348216",
"NCT03579888"
] | 27,280 |
val
|
NCT04004221
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Single-Arm, Multicenter Phase 2 Study of BGB-A317 in Patients With Previously Treated PD-L1+ Locally Advanced or Metastatic Urothelial Bladder Cancer
Brief Summary: This was a single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of the anti- programmed cell death-1(PD-1) monoclonal antibody BGB-A317 in participants with PD-L1+, locally advanced or metastatic Urothelial Bladder Cancer (UBC) who have progressed during or following a platinum-containing regimen
|
{
"A": "Arm Label: Combination Therapy; Type: EXPERIMENTAL; Interventions: Drug: MEDI4736 (Durvalumab), Drug: Tremelimumab | Arm Label: Monotherapy; Type: EXPERIMENTAL; Interventions: Drug: MEDI4736 (Durvalumab) | Arm Label: Standard of Care; Type: ACTIVE_COMPARATOR; Interventions: Drug: Cisplatin, Drug: Carboplatin, Drug: Gemcitabine | Intervention Type: DRUG; Name: MEDI4736 (Durvalumab); Assigned to Arm(s): Combination Therapy, Monotherapy | Intervention Type: DRUG; Name: Tremelimumab; Assigned to Arm(s): Combination Therapy | Intervention Type: DRUG; Name: Cisplatin; Assigned to Arm(s): Standard of Care | Intervention Type: DRUG; Name: Carboplatin; Assigned to Arm(s): Standard of Care | Intervention Type: DRUG; Name: Gemcitabine; Assigned to Arm(s): Standard of Care",
"B": "Arm Label: Arm N - Nivolumab; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab | Arm Label: Arm N-I, Level 1: Nivolumab+Ipilimumab; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab, Biological: Ipilimumab | Arm Label: Arm N-I, Level 2: Nivolumab+Ipilimumab; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab, Biological: Ipilimumab | Arm Label: Arm N-I, Level 2b: Nivolumab+Ipilimumab; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab, Biological: Ipilimumab | Arm Label: Arm N-I, Level 2c: Nivolumab+Ipilimumab; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab, Biological: Ipilimumab | Arm Label: Arm N-I, Level 2d: Nivolumab+Ipilimumab+Cobimetinib; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab, Biological: Ipilimumab, Drug: Cobimetinib | Intervention Type: BIOLOGICAL; Name: Nivolumab; Assigned to Arm(s): Arm N - Nivolumab, Arm N-I, Level 1: Nivolumab+Ipilimumab, Arm N-I, Level 2: Nivolumab+Ipilimumab, Arm N-I, Level 2b: Nivolumab+Ipilimumab, Arm N-I, Level 2c: Nivolumab+Ipilimumab, Arm N-I, Level 2d: Nivolumab+Ipilimumab+Cobimetinib | Intervention Type: BIOLOGICAL; Name: Ipilimumab; Assigned to Arm(s): Arm N-I, Level 1: Nivolumab+Ipilimumab, Arm N-I, Level 2: Nivolumab+Ipilimumab, Arm N-I, Level 2b: Nivolumab+Ipilimumab, Arm N-I, Level 2c: Nivolumab+Ipilimumab, Arm N-I, Level 2d: Nivolumab+Ipilimumab+Cobimetinib | Intervention Type: DRUG; Name: Cobimetinib; Assigned to Arm(s): Arm N-I, Level 2d: Nivolumab+Ipilimumab+Cobimetinib",
"C": "Arm Label: Atezolizumab; Type: EXPERIMENTAL; Interventions: Drug: Atezolizumab | Intervention Type: DRUG; Name: Atezolizumab; Assigned to Arm(s): Atezolizumab",
"D": "Arm Label: Tislelizumab; Type: EXPERIMENTAL; Interventions: Drug: Tislelizumab | Intervention Type: DRUG; Name: Tislelizumab; Assigned to Arm(s): Tislelizumab"
}
|
D
|
[
"NCT02516241",
"NCT01928394",
"NCT02928406",
"NCT04004221"
] | 27,281 |
val
|
NCT04005391
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Home-based Delivery of the Contraceptive Implant in Postpartum Guatemalan Women: a Cluster-randomized Trial
Brief Summary: Abstract
Background: Postpartum contraception is important to prevent unintended and closely spaced pregnancies following childbirth.
Methods: This study is a cluster-randomized trial of communities in rural Guatemala where women receive ante- and postnatal care through a community-based nursing program. When nurses visit women for their postpartum visit in the intervention clusters, instead of providing only routine care that includes postpartum contraceptive education and counseling, the nurses will also bring a range of barrier, short-acting, and long-acting contraceptives that will be offered and administered in the home setting, after routine clinical care is provided.
Discussion: A barrier to postpartum contraception is access to medications and devices. The study removes some access barriers (distance, time, cost) by providing contraception in the home. The community nurses were trained to place implants, which are a type of long-acting reversible contraceptive method that was previously only available in the closest town, which is about an hour away by vehicle. Therefore, the study examines how home-based delivery of routinely available contraceptives and the less routinely available implant may be associated with increased uptake of postpartum contraception within three months of childbirth. The potential implications of this study include: nurses may be able to be trained to safely provide contraceptives, including place implants, in the home setting, and provision of home-based contraception may be an effective way of delivering an evidence-based intervention for preventing unintended and closely spaced pregnancies in the postpartum period.
|
{
"A": "Intervention Type: BEHAVIORAL; Name: Home Nurse Visit; Assigned to Arm(s): N/A",
"B": "Arm Label: Standard care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Delayed rounding; Type: EXPERIMENTAL; Interventions: Behavioral: Delayed rounds | Intervention Type: BEHAVIORAL; Name: Delayed rounds; Assigned to Arm(s): Delayed rounding",
"C": "Arm Label: Postpartum Contraceptives offered to Intervention Clusters; Type: EXPERIMENTAL; Interventions: Other: Offer of Participant's Choice of Contraception Method | Arm Label: Routine Care offered to Control Clusters; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: OTHER; Name: Offer of Participant's Choice of Contraception Method; Assigned to Arm(s): Postpartum Contraceptives offered to Intervention Clusters",
"D": "Arm Label: Mother Touch Program; Type: EXPERIMENTAL; Interventions: Other: Mothers Touch Program | Arm Label: Usual care Program; Type: OTHER; Interventions: Other: Usual Care Program | Intervention Type: OTHER; Name: Mothers Touch Program; Assigned to Arm(s): Mother Touch Program | Intervention Type: OTHER; Name: Usual Care Program; Assigned to Arm(s): Usual care Program"
}
|
C
|
[
"NCT00360204",
"NCT02432573",
"NCT04005391",
"NCT03715218"
] | 27,282 |
val
|
NCT04009239
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Time Restricted Feeding and Metabolic Rhythms
Brief Summary: Current guidelines for the prevention and treatment of obesity focus on caloric restriction diets and increasing physical activity, but long-term compliance to these strategies is poor. The timing of meal intake relative to the light-dark and sleep-wake cycle is rarely considered in metabolic health; and modifying meal timing is likely easier to implement in daily life than reducing caloric intake and/or increasing physical activity. This project will test whether restricting the timing of energy intake to a short-defined period during wakefulness can be used to improve fuel utilization patterns and enhance circadian rhythms in metabolic tissues to optimize health.
|
{
"A": "Arm Label: Early Time Restricted Feeding; Type: EXPERIMENTAL; Interventions: Behavioral: Time Restricted Feeding | Arm Label: Mid-day Time Restricted Feeding; Type: EXPERIMENTAL; Interventions: Behavioral: Time Restricted Feeding | Intervention Type: BEHAVIORAL; Name: Time Restricted Feeding; Assigned to Arm(s): Early Time Restricted Feeding, Mid-day Time Restricted Feeding",
"B": "Arm Label: Normal Feeding; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Time Restricted Feeding; Type: EXPERIMENTAL; Interventions: Behavioral: Time Restricted Feeding | Intervention Type: BEHAVIORAL; Name: Time Restricted Feeding; Assigned to Arm(s): Time Restricted Feeding",
"C": "Arm Label: Time-Restricted Feeding (early in the day eating); Type: EXPERIMENTAL; Interventions: Other: Time-Restricted Feeding | Arm Label: Grazing; Type: PLACEBO_COMPARATOR; Interventions: Other: Grazing | Intervention Type: OTHER; Name: Time-Restricted Feeding; Assigned to Arm(s): Time-Restricted Feeding (early in the day eating) | Intervention Type: OTHER; Name: Grazing; Assigned to Arm(s): Grazing",
"D": "Arm Label: Lifestyle counseling; Type: EXPERIMENTAL; Interventions: Behavioral: CHARMS | Intervention Type: BEHAVIORAL; Name: CHARMS; Assigned to Arm(s): Lifestyle counseling"
}
|
A
|
[
"NCT04009239",
"NCT02970188",
"NCT01895179",
"NCT01741298"
] | 27,283 |
val
|
NCT04009304
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effective Training Models for Implementing Health-Promoting Practices Afterschool
Brief Summary: This study of the dissemination of the Out-of-school Nutrition and Physical Activity Initiative will utilize a 3-arm group-randomized control trial to establish the effectiveness of two learning collaborative training models (e.g. train-the-trainer in-person vs. online) for an evidence-based out-of-school time (OST) nutrition and physical activity intervention. The study will compare sites that receive the training models with a control group. Investigators will work with YMCA leadership to recruit 45 demographically diverse YMCA OST sites from across the country. Sites will be matched on racial/ethnic composition, proportion of students eligible for free or reduced price meals, program enrollment, urban/rural/suburban setting, and physical activity and food service facilities available. One-third of the sites will be randomized to participate in the online training over the school year, one-third will participate in the in-person train-the-trainer model, and one-third will serve as controls. After randomization, in fall 2016, teams of YMCA OST directors and line staff will be invited to participate in the OSNAP learning collaborative trainings. The intervention follows the social ecological model with activities targeting multiple levels of change-school district/program sponsor, OST site, interpersonal, and individual-and emphasizing on adoption of the following OSNAP goals: ban sugar-sweetened drinks from snacks served and brought in from outside the snack program; offer water as a drink at snack every day; offer a fruit or vegetable option every day at snack; ban foods with trans fats from snacks served; serve whole grains; offer 30 minutes of physical activity to all children daily; offer 20 minutes of vigorous physical activity to all children 3 times per week; and eliminate television, movies, and non-educational screentime. Sessions are designed consistent with the Institute for Healthcare Improvement Breakthrough Series Collaborative model and use constructs from social cognitive theory-knowledge and skill development coupled with action planning-to drive environmental and behavior change. Teams of afterschool staff will use the Out-of-School Nutrition and Physical Activity Observational Practice Assessment Tool (OSNAP-OPAT), decision aids, policy writing guides, and other resources available at www.osnap.org to set data-driven goals and implement discrete practice, policy, and communication action steps throughout the year. Staff will also receive training on the Food \& Fun After School curriculum available at foodandfun.org.
|
{
"A": "Arm Label: In-person; Type: EXPERIMENTAL; Interventions: Behavioral: OSNAP | Arm Label: Online; Type: EXPERIMENTAL; Interventions: Behavioral: OSNAP | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: OSNAP; Assigned to Arm(s): In-person, Online",
"B": "Arm Label: Intervention group; Type: EXPERIMENTAL; Interventions: Behavioral: Active play in after school programs (ASP) | Arm Label: Control group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Active play in after school programs (ASP); Assigned to Arm(s): Intervention group",
"C": "Arm Label: HOP'N After-School Program; Type: EXPERIMENTAL; Interventions: Behavioral: HOP'N After-school Program | Intervention Type: BEHAVIORAL; Name: HOP'N After-school Program; Assigned to Arm(s): HOP'N After-School Program",
"D": "Arm Label: SCORES; Type: EXPERIMENTAL; Interventions: Behavioral: America SCORES, Bay Area | Arm Label: Usual care; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: America SCORES, Bay Area; Assigned to Arm(s): SCORES"
}
|
A
|
[
"NCT04009304",
"NCT02954614",
"NCT01015599",
"NCT01156103"
] | 27,284 |
val
|
NCT04011345
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Folic Acid Supplementation in Children With Sickle-Cell Disease: A Randomized Double-Blind Cross-Over Trial
Brief Summary: Folic acid supplementation (1mg/d) is the standard recommendation for Canadian children with Sickle cell disease (SCD), even though it can provide up to six times the recommended intake amount for healthy children. There is growing concern that too much folic acid can be detrimental to health as high folate levels and circulating unmetabolized folic acid (UMFA), which occurs in blood with doses of folic acid as low as 0.2mg/d, have been associated with accelerated growth of some pre-cancerous cells, and altered DNA methylation and gene expression.
To inform the efficacy and potential harm of high-dose folic acid supplementation in Canadian children with SCD, a double-blind randomized controlled cross-over trial is proposed. Children with SCD (n=36, aged 2-19 y) will be recruited from BC Children's Hospital and randomized to initially receive 1 mg/d folic acid or a placebo for 12-weeks (wk). After a 12-wk washout period, treatments will be reversed.
|
{
"A": "Arm Label: Low Dose; Type: ACTIVE_COMPARATOR; Interventions: Drug: Arginine | Arm Label: High Dose; Type: ACTIVE_COMPARATOR; Interventions: Drug: Arginine | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Arginine; Assigned to Arm(s): High Dose, Low Dose | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"B": "Arm Label: L-glutamine; Type: EXPERIMENTAL; Interventions: Drug: L-glutamine | Arm Label: 100% maltodextrin; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: L-glutamine; Assigned to Arm(s): L-glutamine | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 100% maltodextrin",
"C": "Arm Label: L-Arginine Hydrochloride; Type: EXPERIMENTAL; Interventions: Drug: L-Arginine Hydrochloride | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Normal saline | Intervention Type: DRUG; Name: L-Arginine Hydrochloride; Assigned to Arm(s): L-Arginine Hydrochloride | Intervention Type: OTHER; Name: Normal saline; Assigned to Arm(s): Placebo",
"D": "Arm Label: Folic Acid Supplement [Phase 1]; Type: OTHER; Interventions: Dietary Supplement: Folic Acid Supplement, Dietary Supplement: Placebo | Arm Label: Placebo [Phase 1]; Type: OTHER; Interventions: Dietary Supplement: Folic Acid Supplement, Dietary Supplement: Placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: Folic Acid Supplement; Assigned to Arm(s): Folic Acid Supplement [Phase 1], Placebo [Phase 1] | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo; Assigned to Arm(s): Folic Acid Supplement [Phase 1], Placebo [Phase 1]"
}
|
D
|
[
"NCT00513617",
"NCT01179217",
"NCT04839354",
"NCT04011345"
] | 27,285 |
val
|
NCT04012957
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Phase 3, Multicenter, Multi-country, Open-label, Randomized, Active-controlled Clinical Trial to Evaluate the Efficacy and Safety of Desidustat Versus Darbepoetin for the Treatment of Anemia in Patients With Chronic Kidney Disease (CKD) Who Are Not on Dialysis
Brief Summary: This is a phase III, multicenter, multi-country, open-label, randomized, active-controlled clinical trial to evaluate the efficacy and safety of Desidustat versus Darbepoetin for the treatment of anemia in patients with CKD who are not on dialysis. The study will be conducted over a period of up to 30 weeks.
|
{
"A": "Arm Label: GSK1278863 4 mg; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: GSK1278863 6 mg; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: GSK1278863 8 mg; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: GSK1278863 10 mg; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: GSK1278863 12 mg; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: Control; Type: ACTIVE_COMPARATOR; Interventions: Drug: Placebo, Drug: rhEPO | Intervention Type: DRUG; Name: GSK1278863; Assigned to Arm(s): GSK1278863 10 mg, GSK1278863 12 mg, GSK1278863 4 mg, GSK1278863 6 mg, GSK1278863 8 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Control | Intervention Type: DRUG; Name: rhEPO; Assigned to Arm(s): Control",
"B": "Arm Label: Darbepoetin Alfa Injection; Type: EXPERIMENTAL; Interventions: Drug: Darbepoetin Alfa | Arm Label: Desidustat oral tablet; Type: ACTIVE_COMPARATOR; Interventions: Drug: Desidustat Oral Tablet | Intervention Type: DRUG; Name: Desidustat Oral Tablet; Assigned to Arm(s): Desidustat oral tablet | Intervention Type: DRUG; Name: Darbepoetin Alfa; Assigned to Arm(s): Darbepoetin Alfa Injection",
"C": "Arm Label: 0.5 mg GSK1278863; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: 2 mg GSK1278863; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: 5 mg GSK1278863; Type: EXPERIMENTAL; Interventions: Drug: GSK1278863 | Arm Label: rhEPO; Type: ACTIVE_COMPARATOR; Interventions: Drug: rhEPO | Intervention Type: DRUG; Name: GSK1278863; Assigned to Arm(s): 0.5 mg GSK1278863, 2 mg GSK1278863, 5 mg GSK1278863 | Intervention Type: DRUG; Name: rhEPO; Assigned to Arm(s): rhEPO",
"D": "Arm Label: AKB-6548; Type: EXPERIMENTAL; Interventions: Drug: AKB-6548 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: AKB-6548; Assigned to Arm(s): AKB-6548 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo"
}
|
B
|
[
"NCT01977482",
"NCT04012957",
"NCT01587924",
"NCT01906489"
] | 27,286 |
val
|
NCT04013854
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Adjuvant Nivolumab or Ipilimumab + Nivolumab Determined By Pathological Response To A Single Dose Of Neoadjvuant Nivolumab
Brief Summary: Subjects with resectable melanoma will receive neoadjuvant nivolumab followed by surgical resection. Post-operatively, subjects will receive open-label treatment with up to 1 year of adjuvant nivolumab or ipilimumab plus nivolumab as determined by pathologic response at the time of resection.
|
{
"A": "Arm Label: A; Type: ACTIVE_COMPARATOR; Interventions: Drug: ipilimumab | Arm Label: B; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: ipilimumab; Assigned to Arm(s): A | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): B",
"B": "Arm Label: Treatment (dabrafenib, trametinib, surgery); Type: EXPERIMENTAL; Interventions: Drug: Dabrafenib, Other: Laboratory Biomarker Analysis, Procedure: Therapeutic Conventional Surgery, Drug: Trametinib | Intervention Type: DRUG; Name: Dabrafenib; Assigned to Arm(s): Treatment (dabrafenib, trametinib, surgery) | Intervention Type: OTHER; Name: Laboratory Biomarker Analysis; Assigned to Arm(s): Treatment (dabrafenib, trametinib, surgery) | Intervention Type: PROCEDURE; Name: Therapeutic Conventional Surgery; Assigned to Arm(s): Treatment (dabrafenib, trametinib, surgery) | Intervention Type: DRUG; Name: Trametinib; Assigned to Arm(s): Treatment (dabrafenib, trametinib, surgery)",
"C": "Arm Label: Neoadjuvant treatment + Adjuvant treatment; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab, Biological: Ipilimumab | Arm Label: Adjuvant treatment; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab | Arm Label: Neo treat with patho response-driven Adju treat or observation; Type: EXPERIMENTAL; Interventions: Biological: Nivolumab, Biological: Ipilimumab | Intervention Type: BIOLOGICAL; Name: Nivolumab; Assigned to Arm(s): Adjuvant treatment, Neo treat with patho response-driven Adju treat or observation, Neoadjuvant treatment + Adjuvant treatment | Intervention Type: BIOLOGICAL; Name: Ipilimumab; Assigned to Arm(s): Neo treat with patho response-driven Adju treat or observation, Neoadjuvant treatment + Adjuvant treatment",
"D": "Arm Label: Arm A: Adjuvant Nivolumab (Complete Pathological Response); Type: ACTIVE_COMPARATOR; Interventions: Drug: nivolumab | Arm Label: Arm B: Adjuvant Nivolumab (Less than Complete Response); Type: ACTIVE_COMPARATOR; Interventions: Drug: nivolumab | Arm Label: Arm C: Adjuvant Combination (Less than Complete Response); Type: EXPERIMENTAL; Interventions: Drug: nivolumab, Drug: Ipilimumab | Intervention Type: DRUG; Name: nivolumab; Assigned to Arm(s): Arm A: Adjuvant Nivolumab (Complete Pathological Response), Arm B: Adjuvant Nivolumab (Less than Complete Response), Arm C: Adjuvant Combination (Less than Complete Response) | Intervention Type: DRUG; Name: Ipilimumab; Assigned to Arm(s): Arm C: Adjuvant Combination (Less than Complete Response)"
}
|
D
|
[
"NCT00636168",
"NCT02231775",
"NCT04495010",
"NCT04013854"
] | 27,287 |
val
|
NCT04013854
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Adjuvant Nivolumab or Ipilimumab + Nivolumab Determined By Pathological Response To A Single Dose Of Neoadjvuant Nivolumab
Brief Summary: Subjects with resectable melanoma will receive neoadjuvant nivolumab followed by surgical resection. Post-operatively, subjects will receive open-label treatment with up to 1 year of adjuvant nivolumab or ipilimumab plus nivolumab as determined by pathologic response at the time of resection.
|
{
"A": "Arm Label: A; Type: EXPERIMENTAL; Interventions: Drug: Nivolumab | Arm Label: B; Type: EXPERIMENTAL; Interventions: Drug: Domatinostat, Drug: Nivolumab | Arm Label: C; Type: EXPERIMENTAL; Interventions: Drug: Domatinostat, Drug: Nivolumab | Arm Label: D; Type: EXPERIMENTAL; Interventions: Drug: Domatinostat, Drug: Nivolumab, Drug: Ipilimumab | Intervention Type: DRUG; Name: Domatinostat; Assigned to Arm(s): B, C, D | Intervention Type: DRUG; Name: Nivolumab; Assigned to Arm(s): A, B, C, D | Intervention Type: DRUG; Name: Ipilimumab; Assigned to Arm(s): D",
"B": "Arm Label: Arm I (aldesleukin); Type: EXPERIMENTAL; Interventions: Biological: Aldesleukin, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Other: Laboratory Biomarker Analysis | Arm Label: Arm II (gp100 antigen in Montanide IDA-51 and aldesleukin); Type: EXPERIMENTAL; Interventions: Biological: Aldesleukin, Biological: gp100 Antigen, Drug: Montanide ISA 51 VG, Other: Quality-of-Life Assessment, Other: Questionnaire Administration, Other: Laboratory Biomarker Analysis | Intervention Type: BIOLOGICAL; Name: Aldesleukin; Assigned to Arm(s): Arm I (aldesleukin), Arm II (gp100 antigen in Montanide IDA-51 and aldesleukin) | Intervention Type: BIOLOGICAL; Name: gp100 Antigen; Assigned to Arm(s): Arm II (gp100 antigen in Montanide IDA-51 and aldesleukin) | Intervention Type: DRUG; Name: Montanide ISA 51 VG; Assigned to Arm(s): Arm II (gp100 antigen in Montanide IDA-51 and aldesleukin) | Intervention Type: OTHER; Name: Quality-of-Life Assessment; Assigned to Arm(s): Arm I (aldesleukin), Arm II (gp100 antigen in Montanide IDA-51 and aldesleukin) | Intervention Type: OTHER; Name: Questionnaire Administration; Assigned to Arm(s): Arm I (aldesleukin), Arm II (gp100 antigen in Montanide IDA-51 and aldesleukin) | Intervention Type: OTHER; Name: Laboratory Biomarker Analysis; Assigned to Arm(s): Arm I (aldesleukin), Arm II (gp100 antigen in Montanide IDA-51 and aldesleukin)",
"C": "Arm Label: Arm I (paclitaxel, carboplatin, sorafenib tosylate); Type: EXPERIMENTAL; Interventions: Drug: Carboplatin, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel, Other: Pharmacological Study, Drug: Sorafenib Tosylate | Arm Label: Arm II (carboplatin, paclitaxel, placebo); Type: ACTIVE_COMPARATOR; Interventions: Drug: Carboplatin, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel, Other: Pharmacological Study, Other: Placebo | Intervention Type: DRUG; Name: Carboplatin; Assigned to Arm(s): Arm I (paclitaxel, carboplatin, sorafenib tosylate), Arm II (carboplatin, paclitaxel, placebo) | Intervention Type: OTHER; Name: Laboratory Biomarker Analysis; Assigned to Arm(s): Arm I (paclitaxel, carboplatin, sorafenib tosylate), Arm II (carboplatin, paclitaxel, placebo) | Intervention Type: DRUG; Name: Paclitaxel; Assigned to Arm(s): Arm I (paclitaxel, carboplatin, sorafenib tosylate), Arm II (carboplatin, paclitaxel, placebo) | Intervention Type: OTHER; Name: Pharmacological Study; Assigned to Arm(s): Arm I (paclitaxel, carboplatin, sorafenib tosylate), Arm II (carboplatin, paclitaxel, placebo) | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Arm II (carboplatin, paclitaxel, placebo) | Intervention Type: DRUG; Name: Sorafenib Tosylate; Assigned to Arm(s): Arm I (paclitaxel, carboplatin, sorafenib tosylate)",
"D": "Arm Label: Arm A: Adjuvant Nivolumab (Complete Pathological Response); Type: ACTIVE_COMPARATOR; Interventions: Drug: nivolumab | Arm Label: Arm B: Adjuvant Nivolumab (Less than Complete Response); Type: ACTIVE_COMPARATOR; Interventions: Drug: nivolumab | Arm Label: Arm C: Adjuvant Combination (Less than Complete Response); Type: EXPERIMENTAL; Interventions: Drug: nivolumab, Drug: Ipilimumab | Intervention Type: DRUG; Name: nivolumab; Assigned to Arm(s): Arm A: Adjuvant Nivolumab (Complete Pathological Response), Arm B: Adjuvant Nivolumab (Less than Complete Response), Arm C: Adjuvant Combination (Less than Complete Response) | Intervention Type: DRUG; Name: Ipilimumab; Assigned to Arm(s): Arm C: Adjuvant Combination (Less than Complete Response)"
}
|
D
|
[
"NCT04133948",
"NCT00019682",
"NCT00110019",
"NCT04013854"
] | 27,288 |
val
|
NCT04015492
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Single Dose, Open Label, Randomized, Cross-over Study in Participants With Severe Hemophilia A Comparing Pharmacokinetic Parameters of BAY 94-9027 and Adynovi
Brief Summary: This study is being conducted to compare how the body distributes and excretes the drugs Jivi (BAY 94-9027) and Adynovi. Jivi is a recently approved blood clotting Factor VIII (FVIII) medication for the treatment of hemophilia A (bleeding disorder resulting from a lack of FVIII). Both drugs are FVIII products which have been manufactured via recombinant technology and have an extended half-live, i.e. they will stay longer in the body than other FVIII products. Therefore these products act longer in the body which reduces the frequency of drug injections. To compare the two drugs, a cross-over design was chosen, i.e. each patient will receive both products one after another.
Patients participating in this study will receive one dose of Jivi and one dose of Adynovi. Both drugs are injected into a vein. Observation will last for about 10 weeks, and blood samples will be taken from the participants to measure the blood levels of FVIII. Generic name of Jivi is Damoctocog-alfa-pegol, generic name of Adynovi is Rurioctocog alfa pegol.
|
{
"A": "Arm Label: Prophylaxis; Type: EXPERIMENTAL; Interventions: Biological: rIX-FP | Arm Label: On-demand; Type: EXPERIMENTAL; Interventions: Biological: rIX-FP | Intervention Type: BIOLOGICAL; Name: rIX-FP; Assigned to Arm(s): On-demand, Prophylaxis",
"B": "Arm Label: Concizumab; Type: EXPERIMENTAL; Interventions: Drug: Concizumab, Drug: placebo | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: Concizumab; Assigned to Arm(s): Concizumab | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Concizumab, Placebo",
"C": "Arm Label: Group 1; Type: N/A; Interventions: Drug: Recombinant Factor VIII (Kogenate FS, BAY14-2222) | Arm Label: Group 2; Type: N/A; Interventions: Drug: Recombinant Factor VIII (Kogenate FS, BAY14-2222) | Intervention Type: DRUG; Name: Recombinant Factor VIII (Kogenate FS, BAY14-2222); Assigned to Arm(s): Group 1 | Intervention Type: DRUG; Name: Recombinant Factor VIII (Kogenate FS, BAY14-2222); Assigned to Arm(s): Group 2",
"D": "Arm Label: BAY94-9027 / Adynovi; Type: EXPERIMENTAL; Interventions: Biological: Damoctocog-alfa-pegol (BAY94-9027, Jivi), Biological: Rurioctocog alfa pegol (Adynovi) | Arm Label: Adynovi / BAY94-9027; Type: EXPERIMENTAL; Interventions: Biological: Damoctocog-alfa-pegol (BAY94-9027, Jivi), Biological: Rurioctocog alfa pegol (Adynovi) | Intervention Type: BIOLOGICAL; Name: Damoctocog-alfa-pegol (BAY94-9027, Jivi); Assigned to Arm(s): Adynovi / BAY94-9027, BAY94-9027 / Adynovi | Intervention Type: BIOLOGICAL; Name: Rurioctocog alfa pegol (Adynovi); Assigned to Arm(s): Adynovi / BAY94-9027, BAY94-9027 / Adynovi"
}
|
D
|
[
"NCT01496274",
"NCT02490787",
"NCT01159587",
"NCT04015492"
] | 27,289 |
val
|
NCT04016246
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Respiratory Effect of the LISA (Less Invasive Surfactant Administration) Method with Sedation by Propofol Versus Absence of Sedation: Double-blind Comparative Randomized Clinical Trial.
Brief Summary: The investigators propose to evaluate premedication with Propofol compared to a control strategy including a placebo with a possible rescue treatment with ketamine to ensure pain control before LISA Procedure . Investigators hypothesize that sedation with Propofol is safe and non-inferior to placebo for the risk of Mechanical Ventilation in the 72 hours following the procedure.
|
{
"A": "Arm Label: PS Group; Type: ACTIVE_COMPARATOR; Interventions: Drug: PS Group | Arm Label: NCPAP Group; Type: EXPERIMENTAL; Interventions: Device: NCPAP Group | Arm Label: ISX Group; Type: EXPERIMENTAL; Interventions: Drug: ISX Group | Intervention Type: DRUG; Name: PS Group; Assigned to Arm(s): PS Group | Intervention Type: DEVICE; Name: NCPAP Group; Assigned to Arm(s): NCPAP Group | Intervention Type: DRUG; Name: ISX Group; Assigned to Arm(s): ISX Group",
"B": "Arm Label: Propofol; Type: EXPERIMENTAL; Interventions: Drug: Propofol-Lipuro | Arm Label: medialipide; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebos | Intervention Type: DRUG; Name: Propofol-Lipuro; Assigned to Arm(s): Propofol | Intervention Type: DRUG; Name: Placebos; Assigned to Arm(s): medialipide",
"C": "Arm Label: Minimally invasive surfactant therapy; Type: ACTIVE_COMPARATOR; Interventions: Device: Minimally invasive surfactant therapy | Arm Label: Continuation on CPAP; Type: SHAM_COMPARATOR; Interventions: Other: Continuation on CPAP | Intervention Type: DEVICE; Name: Minimally invasive surfactant therapy; Assigned to Arm(s): Minimally invasive surfactant therapy | Intervention Type: OTHER; Name: Continuation on CPAP; Assigned to Arm(s): Continuation on CPAP",
"D": "Arm Label: Surfactant and Low Oxygen; Type: EXPERIMENTAL; Interventions: Drug: Surfactant, Drug: Supplemental oxygen with target saturation of 85 to 89% | Arm Label: Surfactant and High Oxygen; Type: EXPERIMENTAL; Interventions: Drug: Surfactant, Drug: Supplemental oxygen with target saturation of 91 to 95% | Arm Label: CPAP and Low Oxygen; Type: EXPERIMENTAL; Interventions: Device: Continuous Positive Airway Pressure (CPAP), Drug: Supplemental oxygen with target saturation of 85 to 89% | Arm Label: CPAP and High Oxygen; Type: EXPERIMENTAL; Interventions: Device: Continuous Positive Airway Pressure (CPAP), Drug: Supplemental oxygen with target saturation of 91 to 95% | Intervention Type: DRUG; Name: Surfactant; Assigned to Arm(s): Surfactant and High Oxygen, Surfactant and Low Oxygen | Intervention Type: DEVICE; Name: Continuous Positive Airway Pressure (CPAP); Assigned to Arm(s): CPAP and High Oxygen, CPAP and Low Oxygen | Intervention Type: DRUG; Name: Supplemental oxygen with target saturation of 85 to 89%; Assigned to Arm(s): CPAP and Low Oxygen, Surfactant and Low Oxygen | Intervention Type: DRUG; Name: Supplemental oxygen with target saturation of 91 to 95%; Assigned to Arm(s): CPAP and High Oxygen, Surfactant and High Oxygen"
}
|
B
|
[
"NCT00244101",
"NCT04016246",
"NCT02140580",
"NCT00233324"
] | 27,290 |
val
|
NCT04016285
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Comparison to Short-duration Tourniquet Total Knee Arthroplasty (TKA) With the Aquamantys® Bipolar Sealer and the Standard of Care in the Setting of Outpatient TKA: A Randomized, Double-blinded Study
Brief Summary: The purpose of this study is to compare quadriceps muscle strength, pain, opioid consumption and patient function during the first three months after short-stay total knee replacement between patients treated with short-duration tourniquet knee replacement with the Aquamantys® bipolar sealer versus those treated with the standard of care (tourniquet used throughout the case and no Aquamantys®).
By doing this study, investigators hope to learn if short duration tourniquet knee replacement with the Aquamantys® bipolar sealer is more effective than standard of care (tourniquet used throughout the case and no Aquamantys®). The purpose of this study is to compare quadriceps muscle strength, pain, opioid consumption and patient function during the first three months after short-stay total knee replacement between patients treated with short-duration tourniquet knee replacement with the Aquamantys® bipolar sealer versus those treated with the standard of care (tourniquet used throughout the case and no Aquamantys®).
|
{
"A": "Arm Label: treatment; Type: EXPERIMENTAL; Interventions: Drug: General Anesthesia | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Neuraxial anesthesia | Intervention Type: DRUG; Name: General Anesthesia; Assigned to Arm(s): treatment | Intervention Type: DRUG; Name: Neuraxial anesthesia; Assigned to Arm(s): Placebo",
"B": "Arm Label: Tourniquet; Type: EXPERIMENTAL; Interventions: Device: Tourniquet | Arm Label: No tourniquet; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Tourniquet; Assigned to Arm(s): Tourniquet",
"C": "Arm Label: tourniquet; Type: EXPERIMENTAL; Interventions: Procedure: Total knee arthroplasty | Arm Label: non-tourniquet; Type: EXPERIMENTAL; Interventions: Procedure: Total knee arthroplasty | Intervention Type: PROCEDURE; Name: Total knee arthroplasty; Assigned to Arm(s): non-tourniquet, tourniquet",
"D": "Arm Label: Aquamantys; Type: EXPERIMENTAL; Interventions: Device: Aquamantys | Arm Label: Standard of Care: Tourniquet; Type: ACTIVE_COMPARATOR; Interventions: Device: Tourniquet | Intervention Type: DEVICE; Name: Aquamantys; Assigned to Arm(s): Aquamantys | Intervention Type: DEVICE; Name: Tourniquet; Assigned to Arm(s): Standard of Care: Tourniquet"
}
|
D
|
[
"NCT01604382",
"NCT01808859",
"NCT02475603",
"NCT04016285"
] | 27,291 |
val
|
NCT04017442
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery: A Prospective Double Blind Randomized Control Trial
Brief Summary: Patients presenting for normal spontaneous vaginal delivery who have a neuraxial anesthestic will be randomized to receive preservative free morphine or saline placebo after delivery.
|
{
"A": "Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo oral capsule, Drug: Paracetamol | Arm Label: Ginger; Type: EXPERIMENTAL; Interventions: Drug: Ginger, Drug: Paracetamol | Arm Label: Paracetamol; Type: ACTIVE_COMPARATOR; Interventions: Drug: Paracetamol | Intervention Type: DRUG; Name: Ginger; Assigned to Arm(s): Ginger | Intervention Type: DRUG; Name: Placebo oral capsule; Assigned to Arm(s): Placebo | Intervention Type: DRUG; Name: Paracetamol; Assigned to Arm(s): Ginger, Paracetamol, Placebo",
"B": "Arm Label: Black tea bag; Type: EXPERIMENTAL; Interventions: Other: Warm water soaked Black Tea Bags | Arm Label: ice packs; Type: ACTIVE_COMPARATOR; Interventions: Other: Frozen perineal pad | Intervention Type: OTHER; Name: Frozen perineal pad; Assigned to Arm(s): ice packs | Intervention Type: OTHER; Name: Warm water soaked Black Tea Bags; Assigned to Arm(s): Black tea bag",
"C": "Arm Label: Morphine; Type: EXPERIMENTAL; Interventions: Drug: Preservative Free Morphine | Arm Label: Saline; Type: PLACEBO_COMPARATOR; Interventions: Drug: Saline | Intervention Type: DRUG; Name: Preservative Free Morphine; Assigned to Arm(s): Morphine | Intervention Type: DRUG; Name: Saline; Assigned to Arm(s): Saline",
"D": "Arm Label: Magnesium sulfate; Type: ACTIVE_COMPARATOR; Interventions: Other: Cold pads soaked in Magnesium sulfate solution | Arm Label: Water; Type: SHAM_COMPARATOR; Interventions: Other: Cold pads soaked in water | Intervention Type: OTHER; Name: Cold pads soaked in Magnesium sulfate solution; Assigned to Arm(s): Magnesium sulfate | Intervention Type: OTHER; Name: Cold pads soaked in water; Assigned to Arm(s): Water"
}
|
C
|
[
"NCT03617900",
"NCT01626287",
"NCT04017442",
"NCT02024256"
] | 27,292 |
val
|
NCT04017585
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Double Blind Randomized Clinical Trial in Subjects With Irritable Bowel Syndrome for the Identification of Gluten Sensitivity
Brief Summary: The aim of our study will be to establish in how many subjects with gastrointestinal symptoms and previous diagnosis of irritable bowel syndrome (IBS), the clinical picture is attributable to non celiac gluten sensitivity (NCGS) or fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs) intolerance. For this purpose, all subjects with IBS will take a low FODMAPs diet, which implies the absence of cereals and consequently of gluten, and those presenting symptom improvement during this dietary treatment, will be exposed to a double-blind gluten or placebo challenge, to make a diagnosis of NCGS.
|
{
"A": "Intervention Type: OTHER; Name: Patients recruitment; Assigned to Arm(s): N/A",
"B": "Arm Label: gluten-containing diet; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Active comparator, gluten-free diet; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Gluten-free diet | Intervention Type: DIETARY_SUPPLEMENT; Name: Gluten-free diet; Assigned to Arm(s): Active comparator, gluten-free diet",
"C": "Arm Label: Gluten challenge; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: Gluten challenge | Arm Label: Placebo challenge; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Placebo challenge | Intervention Type: DIETARY_SUPPLEMENT; Name: Gluten challenge; Assigned to Arm(s): Gluten challenge | Intervention Type: DIETARY_SUPPLEMENT; Name: Placebo challenge; Assigned to Arm(s): Placebo challenge",
"D": "Arm Label: patients with IBS treated with gluten; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: diet containing gluten | Arm Label: patients with IBS treated with placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Diet containing placebo | Intervention Type: DIETARY_SUPPLEMENT; Name: diet containing gluten; Assigned to Arm(s): patients with IBS treated with gluten | Intervention Type: DIETARY_SUPPLEMENT; Name: Diet containing placebo; Assigned to Arm(s): patients with IBS treated with placebo"
}
|
D
|
[
"NCT02823522",
"NCT01116505",
"NCT02472704",
"NCT04017585"
] | 27,293 |
val
|
NCT04019704
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: AXS-05-MDD-301: A Randomized, Double-Blind, Placebo-Controlled Trial of AXS-05 in Subjects With Major Depressive Disorder
Brief Summary: A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).
|
{
"A": "Arm Label: A: Ketamine + Naltrexone or placebo; Type: EXPERIMENTAL; Interventions: Drug: Naltrexone | Arm Label: B: Ketamine + Naltrexone or placebo; Type: EXPERIMENTAL; Interventions: Drug: Naltrexone | Intervention Type: DRUG; Name: Naltrexone; Assigned to Arm(s): A: Ketamine + Naltrexone or placebo, B: Ketamine + Naltrexone or placebo",
"B": "Arm Label: Part 1: Block A MK-8777; Type: EXPERIMENTAL; Interventions: Drug: MK-8777 | Arm Label: Part 1: Block A Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Part 1: Block B MK-8777; Type: EXPERIMENTAL; Interventions: Drug: MK-8777 | Arm Label: Part 1: Block B Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Part 1: Block C MK-8777; Type: EXPERIMENTAL; Interventions: Drug: MK-8777 | Arm Label: Part 1: Block C Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Part 1: Block D MK-8777; Type: EXPERIMENTAL; Interventions: Drug: MK-8777 | Arm Label: Part 1: Block D Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Part 2: MK-8777 200 mg; Type: EXPERIMENTAL; Interventions: Drug: MK-8777 | Arm Label: Part 2: MK-8777 800 mg; Type: EXPERIMENTAL; Interventions: Drug: MK-8777 | Arm Label: Part 2: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: MK-8777; Assigned to Arm(s): Part 1: Block A MK-8777, Part 1: Block B MK-8777, Part 1: Block C MK-8777, Part 1: Block D MK-8777, Part 2: MK-8777 200 mg, Part 2: MK-8777 800 mg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Part 1: Block A Placebo, Part 1: Block B Placebo, Part 1: Block C Placebo, Part 1: Block D Placebo, Part 2: Placebo",
"C": "Arm Label: Riluzole; Type: EXPERIMENTAL; Interventions: Drug: Riluzole | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Riluzole; Assigned to Arm(s): Riluzole | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"D": "Arm Label: AXS-05; Type: EXPERIMENTAL; Interventions: Drug: AXS-05 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: AXS-05; Assigned to Arm(s): AXS-05 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo"
}
|
D
|
[
"NCT02911597",
"NCT00610649",
"NCT00054704",
"NCT04019704"
] | 27,294 |
val
|
NCT04019704
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: AXS-05-MDD-301: A Randomized, Double-Blind, Placebo-Controlled Trial of AXS-05 in Subjects With Major Depressive Disorder
Brief Summary: A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).
|
{
"A": "Arm Label: Omega-3; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Smoothie 1g Eicosapentaneoic Acid (EPA) and 1g Docoshaexanoic Acid (DHA) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Smoothie 1g Eicosapentaneoic Acid (EPA) and 1g Docoshaexanoic Acid (DHA) | Intervention Type: DIETARY_SUPPLEMENT; Name: Smoothie 1g Eicosapentaneoic Acid (EPA) and 1g Docoshaexanoic Acid (DHA); Assigned to Arm(s): Omega-3, Placebo",
"B": "Arm Label: AXS-05; Type: EXPERIMENTAL; Interventions: Drug: AXS-05 | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: AXS-05; Assigned to Arm(s): AXS-05 | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo",
"C": "Arm Label: Active; Type: EXPERIMENTAL; Interventions: Drug: Ketamine | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Saline | Intervention Type: DRUG; Name: Ketamine; Assigned to Arm(s): Active | Intervention Type: DRUG; Name: Saline; Assigned to Arm(s): Placebo",
"D": "Arm Label: AZD6765 75 mg; Type: EXPERIMENTAL; Interventions: Drug: AZD6765 | Arm Label: AZD6765 150 mg; Type: EXPERIMENTAL; Interventions: Drug: AZD6765 | Arm Label: Ketamine 0.5 mg/kg; Type: ACTIVE_COMPARATOR; Interventions: Drug: Ketamine | Arm Label: 125 mL sterile NaCl 0.9%; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: AZD6765; Assigned to Arm(s): AZD6765 75 mg | Intervention Type: DRUG; Name: AZD6765; Assigned to Arm(s): AZD6765 150 mg | Intervention Type: DRUG; Name: Ketamine; Assigned to Arm(s): Ketamine 0.5 mg/kg | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): 125 mL sterile NaCl 0.9%"
}
|
B
|
[
"NCT04210804",
"NCT04019704",
"NCT00680433",
"NCT01130909"
] | 27,295 |
val
|
NCT04020484
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Live-Online Mindfulness-based Intervention for Families of Children With Epilepsy: Making Mindfulness Matter© Randomized Control Trial
Brief Summary: Epilepsy is a debilitating condition characterized by spontaneous, unprovoked seizures. Up to 80% of children with epilepsy (CWE) may face cognitive, psychiatric, and/or behavioral comorbidities with significant unmet mental health needs. Mindfulness-based interventions may provide an ideal vector to target unmet mental healthcare needs in patients with epilepsy and their families. The investigators propose the Making Mindfulness Matter© (M3) program as an intervention to improve health related quality of life and mental-health for CWE and their parents. M3 is live-online parent and child program that incorporates mindful awareness, social-emotional learning skills, neuroscience, and positive psychology. This pilot RCT is needed to refine the implementation of the intervention to families with a child with epilepsy, and collect information pertaining to the feasibility and effectiveness of the intervention in preparation for a subsequent multi-centred trial across Canada. Note: Due to COVID-19, the format has been modified for online delivery (from community-based) and the intervention has been restarted.
|
{
"A": "Arm Label: Intervention Group; Type: EXPERIMENTAL; Interventions: Behavioral: Making Mindfulness Matter© (M3) | Arm Label: Waitlist Control; Type: OTHER; Interventions: Behavioral: Making Mindfulness Matter© (M3) | Intervention Type: BEHAVIORAL; Name: Making Mindfulness Matter© (M3); Assigned to Arm(s): Intervention Group, Waitlist Control",
"B": "Arm Label: AMOR Method; Type: EXPERIMENTAL; Interventions: Behavioral: The AMOR Method | Arm Label: Wait List; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: The AMOR Method; Assigned to Arm(s): AMOR Method",
"C": "Arm Label: Care-as-usual (CAU) only; Type: OTHER; Interventions: Other: Care-as-usual for children (8-16 years old) with ADHD | Arm Label: Mindfulness for child and parent + CAU; Type: EXPERIMENTAL; Interventions: Other: MYmind mindfulness training, Other: Care-as-usual for children (8-16 years old) with ADHD | Intervention Type: OTHER; Name: MYmind mindfulness training; Assigned to Arm(s): Mindfulness for child and parent + CAU | Intervention Type: OTHER; Name: Care-as-usual for children (8-16 years old) with ADHD; Assigned to Arm(s): Care-as-usual (CAU) only, Mindfulness for child and parent + CAU",
"D": "Arm Label: lifestyle; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Lifestyle counseling | Arm Label: therapy; Type: EXPERIMENTAL; Interventions: Behavioral: Lifestyle counseling, Behavioral: Parenting Mindfully for Health (PMH) | Intervention Type: BEHAVIORAL; Name: Lifestyle counseling; Assigned to Arm(s): lifestyle, therapy | Intervention Type: BEHAVIORAL; Name: Parenting Mindfully for Health (PMH); Assigned to Arm(s): therapy"
}
|
A
|
[
"NCT04020484",
"NCT03513419",
"NCT03220308",
"NCT01974102"
] | 27,296 |
val
|
NCT04023942
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Lifestyle Intervention Study
Brief Summary: Despite standardized intervention strategies, weight loss and weight loss maintenance largely differ from person to person. Factors which may contribute to these individual differences is current object of research.
In order to investigate predictors and barriers for weight management and to investigate two different dietary interventions and two different digital tools for weight maintenance, the LION-Study was designed as follows: Step I (screening, baseline phenotyping), step II (weight loss intervention with formula diet), step III (weight maintenance intervention with 4 intervention groups: low carb/newsletter; low carb/app; low fat/newsletter; low fat/app) and step IV (follow-up). Participants are required to attend visits at seven time points.
At screening (month 0) a telephone-based screening interview takes place, in order to test eligibility of the potential participant. If the person is eligible, two consecutive baseline face-to-face visits are planned during step I. After completion of the eight weeks weight loss intervention (month 3), an additional visit takes place followed by three consecutive visits in the weight maintenance step (month 6, 9 and 15). The study ends with a final visit after the follow-up (month 27). Additional contacts (face-to-face and telephone) take place during the weight loss intervention step. Participants will regularly receive a bag with the required formula diet meals. During these "pick up" appointments, the study team actively get in face-to-face contact with participants.
At the different visits, data are collected by questionnaires, medical investigations (e.g. MRI, motor function, resting metabolic rate), blood withdrawal as well as urine, feces and saliva sampling.
Primary objective is to evaluate the effect of two diets (low carb/low fat) and two digital tools (app/newsletter) on long-term weight loss maintenance 12 months after weight loss.
Secondary objective is to identify genetic, epigenetic, physiological, psychological and lifestyle factors that predict the success of weight loss and weight loss maintenance.
|
{
"A": "Arm Label: Low carb - App-based group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Weight maintenance intervention | Arm Label: Low carb - Newsletter-based group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Weight maintenance intervention | Arm Label: Low fat - App-based group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Weight maintenance intervention | Arm Label: Low fat - Newsletter-based group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Weight maintenance intervention | Intervention Type: BEHAVIORAL; Name: Weight maintenance intervention; Assigned to Arm(s): Low carb - App-based group, Low carb - Newsletter-based group, Low fat - App-based group, Low fat - Newsletter-based group",
"B": "Arm Label: Group 1. Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Group 2. Intervention 1; Type: EXPERIMENTAL; Interventions: Behavioral: Intervention 1 | Arm Label: Group 2. Intervention 2; Type: EXPERIMENTAL; Interventions: Behavioral: Intervention 2 | Intervention Type: BEHAVIORAL; Name: Intervention 1; Assigned to Arm(s): Group 2. Intervention 1 | Intervention Type: BEHAVIORAL; Name: Intervention 2; Assigned to Arm(s): Group 2. Intervention 2",
"C": "Arm Label: Smartphone App Participants (APP); Type: EXPERIMENTAL; Interventions: Behavioral: Smartphone App Participants (APP) | Arm Label: Diabetes Prevention Program Participants (DPP); Type: EXPERIMENTAL; Interventions: Behavioral: Diabetes Prevention Program Participants (DPP) | Intervention Type: BEHAVIORAL; Name: Smartphone App Participants (APP); Assigned to Arm(s): Smartphone App Participants (APP) | Intervention Type: BEHAVIORAL; Name: Diabetes Prevention Program Participants (DPP); Assigned to Arm(s): Diabetes Prevention Program Participants (DPP)",
"D": "Arm Label: HABIT Group; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: HABIT | Arm Label: TRE Group; Type: EXPERIMENTAL; Interventions: Behavioral: TRE | Intervention Type: BEHAVIORAL; Name: TRE; Assigned to Arm(s): TRE Group | Intervention Type: BEHAVIORAL; Name: HABIT; Assigned to Arm(s): HABIT Group"
}
|
A
|
[
"NCT04023942",
"NCT02818790",
"NCT04708769",
"NCT04465721"
] | 27,297 |
val
|
NCT04025866
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: The Addition of Aerobic Training to Conventional Rehabilitation After Proximal Femur Fracture: a Randomized Controlled Trial
Brief Summary: The primary purpose of this study is to assess the feasibility of an arm cycle ergometer training in subjects with proximal femur fracture surgically treated. The secondary purpose of this randomized controlled clinical trial is to verify whether the addition of aerobic activity can increase motor performance compared to a conventional exercise program in which no aerobic activity is foreseen.
|
{
"A": "Arm Label: Conventional rehabilitation; Type: ACTIVE_COMPARATOR; Interventions: Other: Conventional rehabilitation | Arm Label: Aerobic exercise; Type: ACTIVE_COMPARATOR; Interventions: Other: Conventional rehabilitation, Other: Aerobic exercise | Intervention Type: OTHER; Name: Conventional rehabilitation; Assigned to Arm(s): Aerobic exercise, Conventional rehabilitation | Intervention Type: OTHER; Name: Aerobic exercise; Assigned to Arm(s): Aerobic exercise",
"B": "Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Exercise Plus Program | Arm Label: 2; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Exercise Plus Program; Assigned to Arm(s): 1",
"C": "Intervention Type: DRUG; Name: cholecalciferol; Assigned to Arm(s): N/A | Intervention Type: BEHAVIORAL; Name: Physiotherapy; Assigned to Arm(s): N/A",
"D": "Arm Label: Home-based physical exercise; Type: EXPERIMENTAL; Interventions: Other: Home-based physical exercise intervention | Arm Label: Control Group Usual Care; Type: OTHER; Interventions: Other: Control Group Usual Care | Intervention Type: OTHER; Name: Home-based physical exercise intervention; Assigned to Arm(s): Home-based physical exercise | Intervention Type: OTHER; Name: Control Group Usual Care; Assigned to Arm(s): Control Group Usual Care"
}
|
A
|
[
"NCT04025866",
"NCT00390741",
"NCT00133640",
"NCT02295527"
] | 27,298 |
val
|
NCT04026594
|
Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Efficacy of Mindfulness-based Therapy vs. Relaxation in Prevention of Burnout in Medical Students : A Multicenter, Single Blind Randomized Controlled Study
Brief Summary: A recent survey exploring mental health in a large cohort of French medical students and young graduates (N = 21.768), observed that 68.2% of participants showed pathologic anxiety. A high level of depressive symptomatology was found in 27.7% of participants, while suicidal ideation was reported by 23.7%. Mindfulness Based Interventions are beneficial for health with a positive impact on mood, anxiety, and well-being. It thus can be hypothesized that such interventions could help to prevent anxio-depressive symptomatology in medical students.
The implementation of prevention programs to promote resilience to stress and empathy among medical students is a priority, included in French National Strategy for Health. Efficacy of Mindfulness Based Interventions in French university must be studied to confirm and strengthen their development. The originality of this project consists in the collaboration of medical schools from different cities and the longitudinal follow-up.
The purpose of this study is to assess the efficacy of a mindfulness-based therapy in burnout prevention in comparison to relaxation.
|
{
"A": "Arm Label: Mindfulness Based Stress Reduction (MBSR); Type: EXPERIMENTAL; Interventions: Other: Mindfulness Based Stress Reduction | Arm Label: Progressive Muscle Relaxation Training (PMRT); Type: ACTIVE_COMPARATOR; Interventions: Other: Relaxation group | Intervention Type: OTHER; Name: Mindfulness Based Stress Reduction; Assigned to Arm(s): Mindfulness Based Stress Reduction (MBSR) | Intervention Type: OTHER; Name: Relaxation group; Assigned to Arm(s): Progressive Muscle Relaxation Training (PMRT)",
"B": "Arm Label: Mindfulness; Type: EXPERIMENTAL; Interventions: Behavioral: Mindfulness | Arm Label: Interpersonal effectiveness; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: interpersonal effectiveness | Intervention Type: BEHAVIORAL; Name: Mindfulness; Assigned to Arm(s): Mindfulness | Intervention Type: BEHAVIORAL; Name: interpersonal effectiveness; Assigned to Arm(s): Interpersonal effectiveness",
"C": "Arm Label: Cohort 1; Type: OTHER; Interventions: Behavioral: Three Good Things, Behavioral: Gratitude, Behavioral: Random Acts of Kindess, Behavioral: Awe, Behavioral: 1 Good Chat | Arm Label: Cohort 2; Type: OTHER; Interventions: Behavioral: Three Good Things, Behavioral: Gratitude, Behavioral: Random Acts of Kindess, Behavioral: Awe, Behavioral: 1 Good Chat | Arm Label: Cohort 3 (July cohort) WISER 2.0; Type: EXPERIMENTAL; Interventions: Behavioral: Three Good Things, Behavioral: Gratitude, Behavioral: Random Acts of Kindess, Behavioral: Awe, Behavioral: 1 Good Chat | Intervention Type: BEHAVIORAL; Name: Three Good Things; Assigned to Arm(s): Cohort 1, Cohort 2, Cohort 3 (July cohort) WISER 2.0 | Intervention Type: BEHAVIORAL; Name: Gratitude; Assigned to Arm(s): Cohort 1, Cohort 2, Cohort 3 (July cohort) WISER 2.0 | Intervention Type: BEHAVIORAL; Name: Random Acts of Kindess; Assigned to Arm(s): Cohort 1, Cohort 2, Cohort 3 (July cohort) WISER 2.0 | Intervention Type: BEHAVIORAL; Name: Awe; Assigned to Arm(s): Cohort 1, Cohort 2, Cohort 3 (July cohort) WISER 2.0 | Intervention Type: BEHAVIORAL; Name: 1 Good Chat; Assigned to Arm(s): Cohort 1, Cohort 2, Cohort 3 (July cohort) WISER 2.0",
"D": "Arm Label: Short-term Compassion Fatigue Resiliency Program; Type: EXPERIMENTAL; Interventions: Behavioral: Compassion Fatigue Resiliency Program (CFRP) | Arm Label: Long-term Compassion Fatigue Resiliency Program; Type: EXPERIMENTAL; Interventions: Behavioral: Compassion Fatigue Resiliency Program (CFRP) | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Compassion Fatigue Resiliency Program (CFRP); Assigned to Arm(s): Long-term Compassion Fatigue Resiliency Program, Short-term Compassion Fatigue Resiliency Program"
}
|
A
|
[
"NCT04026594",
"NCT02397031",
"NCT02603133",
"NCT04372303"
] | 27,299 |
val
|
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