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Clinical Decision Rule

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12421. Apnea Positive Pressure Long-Term Efficacy Study

of this study that can be used to assess the clinical effectiveness of CPAP in improving neurocognitive function, mood, sleepiness, and quality of life; and 5) to use functional magnetic resonance imaging to compare cortical activation before and after CPAP therapy, and to assess whether this change is associated with improvement in specific neurocognitive task performance. The primary endpoint of the study is the effect of six months of CPAP treatment on neurocognitive function. A total of 1100 subjects (...) (550 per treatment group) will be enrolled from the patient populations at five sites (Stanford University; University of Arizona; Brigham and Women's Hospital; Massachusetts; St. Luke's Hospital, Missouri; St. Mary Medical Center, Washington). Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 1105 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider

2003 Clinical Trials

12422. B-Lymphocyte Stimulator (BLyS) To Treat Selective IgA Deficiency

Clinical Center (CC) Study Details Study Description Go to Brief Summary: This study will examine the safety of BlyS, an experimental drug being developed to treat immune deficiency. As of July 17, 2001, 7 persons with common variable immune deficiency (CVID) have received BlyS, with no problems reported. This study will test the safety of the drug in people with IgA deficiency. Patients 18 years of age and older with IgA deficiency who have recurrent or chronic sinus or lung infections or chronic (...) tumorigenicity or allergy/hypersensitivity. Enhanced autoimmunity with immune complex formation could not be ruled out in two mouse studies in which BLyS was administered at higher doses on multiple dosing schedules. Renal changes with glomerular protein deposits were noted in a subset of mice treated at 0.1 and 1.0 mg/kg in the first study and 0.3 and 3.0 mg/kg in the second study. Renal changes have not been reproducible in either of 2 repeat mouse studies designed to replicate conditions on the first

2001 Clinical Trials

12423. Test of A Model of Representational Knowledge Stored in the Human Prefrontal Cortex

Disorders and Stroke (NINDS) Information provided by: National Institutes of Health Clinical Center (CC) Study Details Study Description Go to Brief Summary: This study will examine the underlying mental processes that determine how people understand social behavior, remember information, and think. Language, planning, problem solving, reasoning, social behavior, and memory are the critical parts of cognition that make up daily life. This study will explore the association between performance on various (...) a decision about what appears on the screen (for example, whether a statement is accurate) and answer questions from a test examiner. A skin conductance response (SCR) test may be done along with some of the cognitive tests. SCR uses electrodes (pieces of metal attached to wires) placed on the fingers to measure the subject's emotional reaction to a test. Participants may also do an evoked response test, in which the subject watches words or scenes on a TV screen while his or her responses are recorded

2001 Clinical Trials

12424. PET Scanning in Parkinson s Disease

is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT00024622 Recruitment Status : Recruiting First Posted : September 24, 2001 Last Update Posted : March 22, 2019 See Sponsor: National Institute of Mental Health (NIMH) Information provided by: National Institutes of Health Clinical Center (...) with Schizophrenia Spectrum Disorders and Their Siblings, PI: Karen F. Berman, MD. We also draw comparisons between subjects with inherited vs. sporadic Parkinson s disease to determine whether the PET phenotype is the same in both groups, and we compare system-level, circuit-based pathophysiology across PD and schizophrenia groups. Each subject is further screened with an MRI to rule out structural abnormalities and also to further delineate areas of interest in the PET scans Condition or disease Parkinson's

2001 Clinical Trials

12425. Expanded Access Study of Iodine-131 Anti-B1 Antibody

information Study Type : Interventional (Clinical Trial) Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: Expanded Access Study of Iodine-131 Anti-B1 Antibody for Relapsed/Refractory Low-Grade and Transformed Low-Grade Non-Hodgkin's Lymphoma Study Start Date : September 1998 Resource links provided by the National Library of Medicine related topics: available for: resources: Arms and Interventions Go to Outcome (...) Measures Go to Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes

2001 Clinical Trials

12426. Safety and Efficacy of Iodine-131 Anti-B1 Antibody for Intermediate Grade Non-Hodgkin's Lymphoma Following First Line CHOP

Go to Layout table for study information Study Type : Interventional (Clinical Trial) Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: Phase II Multicenter Study of Iodine-131 Anti-B1 Antibody Consolidation For Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma Following First-Line CHOP Study Start Date : January 2000 Resource links provided by the National Library of Medicine related topics (...) : available for: resources: Arms and Interventions Go to Outcome Measures Go to Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages

2001 Clinical Trials

12427. Safety and Efficacy of Iodine-131 Anti-B1 Antibody for NHL Patients With Greater Than 25% Bone Marrow Involvement

, safety, and survival. The dose escalation will be started at 45cGy and will be escalated in 10cGy increments until the maximum tolerated dose in reached. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Enrollment : 24 participants Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: Phase I, Dose-Escalation Study of Iodine-131 Anti-B1 Antibody For Patients (...) With Previously Treated Non-Hodgkin's Lymphoma With More Than 25% Bone Marrow Involvement Study Start Date : May 1999 Resource links provided by the National Library of Medicine related topics: available for: resources: Arms and Interventions Go to Outcome Measures Go to Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn

2001 Clinical Trials

12428. Safety and Efficacy Study of Iodine-131 Anti-B1 Antibody for the Retreatment of Patients With Non-Hodgkin's Lymphoma

months to Iodine-131 Anti-B1 Antibody therapy. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: Retreatment Study of Patients With Non-Hodgkin's Lymphoma Who Have Previously Responded to Iodine-131 Anti-B1 Antibody. Resource links provided by the National Library of Medicine related topics: available (...) for: resources: Arms and Interventions Go to Outcome Measures Go to Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study

2001 Clinical Trials

12429. Safety and Efficacy Study of Iodine-131 Anti-B1 Antibody for Chronic Lymphocytic Leukemia

by groups in 10cGy increments until the maximum tolerated dose (MTD) is reached. Subsequently, patients with platelet counts from 75,000-100,000 cells/mm3 (Cohort B) will be enrolled starting at 10cGy below the MTD reached in Cohort A and the dose will be escalated in 10cGy increments up to the MTD. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Enrollment : 30 participants Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking (...) in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Patients must fulfill the criteria

2001 Clinical Trials

12430. Combination Chemotherapy After Surgery in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer

every 6 months for 5 years, and yearly follow-up thereafter. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 1086 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: Low-dose Cytotoxics as "Anti-angiogenesis Treatment" Following Adjuvant Induction Chemotherapy for Patients With ER-negative and PgR-negative Breast Cancer Study Start Date (...) to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 18 Years to 120 Years (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy

2001 Clinical Trials

12431. Cost-effectiveness of educational interventions to improve patient outcomes in blood pressure control. (Abstract)

regimens, (b) an educational meeting with a member of the patient's family to aid in management at home, and (c) a series of small group sessions to help patients overcome personal barriers to management. We observed consistent results for six different effectiveness measures under a variety of decision-making rules. Our results suggest that in the absence of targeting of multiple interventions to systematically selected high-risk patients, multiple intervention combinations are not more cost-effective (...) Cost-effectiveness of educational interventions to improve patient outcomes in blood pressure control. To examine the relative cost-effectiveness of single versus multiple patient education strategies to reduce hypertension, we assigned patients to seven intervention groups and to a usual-care control group using a randomized factorial design. We compared cost-effectiveness measures for single, double, and triple combinations of (a) a clinic exit interview with patients to clarify their medical

1985 Preventive Medicine Controlled trial quality: uncertain

12432. Quality control in the Multiple Risk Factor Intervention Trial Nutrition Modality. (Abstract)

a nutrition intervention program. Collection of data to monitor changes in dietary intake over time in SI and UC groups, as well as information to assess dietary adherence levels in SI participants also presented large-scale challenges in maintenance of quality control. The MRFIT formulated many of its initial nutrition intervention and data collection decisions based on experience of the earlier National Diet Heart Study (NDHS). In order to avoid coding 7-day dietary records by local clinic nutritionists (...) (as in NDHS), the trial opted for collection of 24-hour dietary recalls that were coded centrally at the Nutrition Coding Center. It necessitated extra attention to training and certification of clinic nutritionist-interviewers to be certain that NCC coders had sufficiently precise information about all foods entered on dietary recall forms. Since dietary intake data were collected over a time span of approximately 10 years, procedures for updating the food composition database and coding rules were

1986 Controlled clinical trials

12433. Nutrition Intervention in Treating Women With Breast Cancer

Adult) Sexes Eligible for Study: Female Accepts Healthy Volunteers: No Criteria DISEASE CHARACTERISTICS: Histologically proven, invasive, localized carcinoma of the breast Stage I/II/IIIA disease, i.e.: Tumor confined to breast on clinical examination Overlying skin movable with respect to tumor Tumor movable in relation to underlying muscle and chest wall Bone scan and/or x-ray required to rule out bone metastases in cases of skeletal pain Tumor size requirements: No greater than 5 cm if lymph (...) Study Description Go to Brief Summary: RATIONALE: Dietary fat may be involved in the growth of cancer cells. Restricting dietary fat may help fight cancer. PURPOSE: Randomized clinical trial to study the effectiveness of a low fat diet in treating postmenopausal women who have stage I, stage II, or stage IIIA breast cancer that has been completely removed by surgery. Condition or disease Intervention/treatment Phase Breast Cancer Other: educational intervention Procedure: therapeutic dietary

1999 Clinical Trials

12434. Combination Chemotherapy Followed by Bone Marrow or Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Germ Cell Tumors

hour on days -5 through -3. Autologous PBSC or bone marrow is reinfused on day 0. PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Primary Purpose: Treatment Official Title: INTENSIVE CHEMOTHERAPY FOR RELAPSED OR REFRACTORY GERM CELL TUMORS EMPLOYING HIGH-DOSE CARBOPLATIN, ETOPOSIDE, AND THIOTEPA WITH AUTOLOGOUS BONE MARROW RESCUE FOR PATIENTS 15 TO 60 YEARS OF AGE Study (...) Start Date : November 1990 Actual Primary Completion Date : September 2001 Actual Study Completion Date : September 2001 Resource links provided by the National Library of Medicine related topics: resources: Arms and Interventions Go to Outcome Measures Go to Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more

1999 Clinical Trials

12435. Combination Chemotherapy and Radiation Therapy in Treating Patients With Peripheral Neuroectodermal Tumors, Ewing's Sarcoma, Wilms' Tumor, or Bone Cancer

by ifosfamide IV over 1 hour on days 1-5. Patients are followed monthly for 18 months and then every 6 months for 18 months. PROJECTED ACCRUAL: A maximum of 50 patients (25 per stratum) will be accrued for this study within 5 years. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Primary Purpose: Treatment Official Title: Phase II Study of Cyclophosphamide, Doxorubicin, Vincristine, Etoposide, and Ifosfamide, Followed by Resection and Radiotherapy (...) in Patients With Peripheral Primitive Neuroectodermal Tumors or Ewing's Sarcoma Study Start Date : May 1990 Actual Primary Completion Date : May 2005 Actual Study Completion Date : May 2005 Resource links provided by the National Library of Medicine related topics: related topics: resources: Arms and Interventions Go to Outcome Measures Go to Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your

1999 Clinical Trials

12436. Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients

for study information Study Type : Interventional (Clinical Trial) Enrollment : 150 participants Masking: Double Primary Purpose: Prevention Official Title: Primary Prophylaxis of Cerebral Toxoplasmosis in HIV-Infected Patients Actual Study Completion Date : May 1994 Resource links provided by the National Library of Medicine related topics: available for: resources: Arms and Interventions Go to Outcome Measures Go to Eligibility Criteria Go to Information from the National Library of Medicine Choosing (...) to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 13 Years and older (Child, Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria Concurrent

1999 Clinical Trials

12437. A Treatment IND for Retrovir Brand Zidovudine (AZT) Therapy of Pediatric Patients With HIV Disease

immunoglobulin levels (IgG or IgA). Decreased helper/suppressor ratio < 1.0. Note: In general, abnormal values for any of the above lab tests should be confirmed in 2 measurements at least 1 week apart, and other clinical causes for these abnormalities should be ruled out. Criteria for children 15 months to 12 years of age: Patient must be HIV antibody-positive by repeated reactive screening test (e.g., ELISA) and positive confirmatory test (e.g., Western blot). OR If antibody-negative, patient must have two (...) improvements in clinical, immunologic, and virologic parameters with administration of AZT. Condition or disease Intervention/treatment Phase HIV Infections Drug: Zidovudine Not Applicable Detailed Description: Previous studies with pediatric patients have shown improvements in clinical, immunologic, and virologic parameters with administration of AZT. This Treatment IND (investigational new drug) is an open label, uncontrolled protocol. AZT is ordered and prescribed by the patient's physician

1999 Clinical Trials

12438. Etoposide Plus Radiation Therapy Followed by Combination Chemotherapy in Treating Children With Newly Diagnosed Advanced Medulloblastoma

) ] It is possible that unacceptably high levels of toxicity may arise. For this reason, there is a 3-stage stopping rule designed to allow the Study Coordinator to stop this study early if it appears that the true proportion of eligible patients who suffer unacceptable levels of toxicity exceeds 10%. Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding (...) Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 53 participants Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Phase I/II Feasibility Study of Oral Etoposide Given Concurrently With Radiotherapy Followed With Dose Intensive Adjuvant Chemotherapy for Children With Newly Diagnosed High Stage Medulloblastoma Study Start Date : November 1998 Actual

1999 Clinical Trials

12439. Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia

weeks for 1 year. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 240 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment Official Title: A Randomized Phase III Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin as Primary Management for Low Risk Gestational Trophoblastic Neoplasia Study Start Date : June 1999 Actual Primary Completion (...) at enrollment. A decline is defined as a decrease by 1 or more units between enrollment and treatment start. Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Layout table

1999 Clinical Trials

12440. Cyclophosphamide and Prednisone Followed by Methotrexate To Treat Vasculitides

) Information provided by: National Institutes of Health Clinical Center (CC) Study Details Study Description Go to Brief Summary: This study will evaluate the safety and effectiveness of a staged approach to therapy for Wegener's granulomatosis and other systemic vasculitides using prednisone plus cyclophosphamide followed by methotrexate. Vasculitides involve inflammation of blood vessels (vasculitis) that may affect the brain, nerves, eyes, sinuses, lungs, kidneys, intestinal tract, skin, joints, heart (...) Date : March 1995 Study Completion Date : March 2004 Resource links provided by the National Library of Medicine related topics: related topics: available for: resources: Groups and Cohorts Go to Outcome Measures Go to Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor

1999 Clinical Trials

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