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15621. Safety and Efficacy Study of AVI-5126 When Used on Vein Grafts Before Use in Heart by-Pass Graft Surgery (CABG)

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: Subject is ≥ 18 years of age Subject is a suitable (...) been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site. Exclusion Criteria: Subject will have valve replacement or repair during CABG procedure Subject has a poor quality donor vessel (poor or turbulent flow, varicose) Subject has a known left ventricular ejection fraction of <35% Subject has had a percutaneous coronary intervention (PCI

2007 Clinical Trials

15622. Clinical Study of Spinal Muscular Atrophy

begins in childhood and leads to significant disability. SMA is caused by a defect in the "Survival of Motor Neurons" (SMN1) gene. Researchers are hopeful to find a cure, because nature has provided humans with a second gene, almost an identical copy of the SMN1 gene. Normally, the second gene does not contribute much, but researchers think that its function can be increased by medications. To find out whether these medications help patients with SMA, we have to conduct clinical trials. Here, we (...) propose to prepare for clinical trials. We will invite SMA patients to join our research effort. We will examine them regularly to better understand their disease. The visits will include questions, physical exam, blood drawing, and sometimes X-rays and a skin biopsy. We will use modern computer methods to process the information. While we are doing this, we will plan a clinical trial. Once the clinical trial begins, we will offer SMA patients participation if they meet the criteria for that trial. We

2007 Clinical Trials

15623. Interactive Voice Response Telephone Technology for the Treatment of Smoking in Patients With Heart Disease

Update Posted : April 29, 2011 Sponsor: Ottawa Heart Institute Research Corporation Collaborator: Heart and Stroke Foundation of Ontario Information provided by: Ottawa Heart Institute Research Corporation Study Details Study Description Go to Brief Summary: A randomized control trial is planned to evaluate an interactive voice response (IVR) mediated follow-up and triage system, against usual care, to help smokers hospitalized with Coronary Heart Disease (CHD) to quit smoking. The investigators (...) follow-up and linkage to community-based smoking cessation resources. Interactive voice response (IVR) technology has the potential to improve follow-up with smokers after hospitalization and to enhance triage to clinical support for smoking cessation. IVR uses natural language to place automated out-going calls that can pose questions regarding smoking status and progress with smoking cessation, that is then dropped into a database. A counselor is then able to link with the database and obtain

2007 Clinical Trials

15624. SPECS: Safe Pediatric Euglycemia in Cardiac Surgery

recovery in young children undergoing heart surgery. Condition or disease Intervention/treatment Phase Heart Defects, Congenital Hyperglycemia Drug: Insulin Other: Usual Care Not Applicable Detailed Description: Children undergoing heart surgery are under significant bodily stress, which can lead to higher than normal or lower than normal blood glucose levels. A synthetic form of insulin, a naturally occurring hormone in the body, can be injected into people to normalize blood glucose levels. Insulin (...) the hospital prior to 30 days, status is determined by a follow-up phone call to the family. Cardiac Function [ Time Frame: The duration of vasoactive support was evaluated from the day of postoperative cardiac ICU admission until the last day of vasoactive support or day of death from any cause, whichever came first, assessed up to 30 days. ] Cardiac function is assessed by duration of vasoactive support. Immune Function [ Time Frame: Post-operative day 7. ] Immune function is assessed by C-reactive

2007 Clinical Trials

15625. Safety and Efficacy Study of In-111 Pentetreotide to Treat Neuroendocrine Tumors

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 Eligible for Study: All Accepts Healthy Volunteers: No Criteria (...) Inclusion Criteria: Patients must have received first line standard chemotherapy and/or radiation therapy for neuroendocrine malignancy in the past and failed the therapy. Patients must have evidence of residual multifocal active tumor. All patients must sign an informed consent indicating the awareness of the investigational nature of the studies involved. All patients must have a Karnofsky performance status of at least 60. Patients must be greater than 18 years of age. Patients must have measurable

2007 Clinical Trials

15626. Morbidity and Mortality Among Dialysis Patients After Treatment for Depression

in dialysis patients, but subsequent impact on outcome after treatment of depression has not been reported. To examine the rates of recovery from depression over a 6-month and 12-month period among prevalent dialysis patients. Rates of recovery among dialysis patients with depression are unclear. The natural history of depression among dialysis patients may help long-term management. Plan and Methods This project is a longitudinal prospective cohort study comprised of dialysis patients from outpatient (...) 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

2007 Clinical Trials

15627. Safety and Efficacy of Obatoclax Mesylate (GX15-070MS)in Combination With Docetaxel for the Treatment of Non-Small Cell Lung Cancer

Recruitment Status : Completed First Posted : December 4, 2006 Last Update Posted : July 21, 2016 Sponsor: Gemin X Information provided by (Responsible Party): Teva Pharmaceutical Industries ( Gemin X ) Study Details Study Description Go to Brief Summary: Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogneic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating (...) the natural process of cell death that is often inhibited in cancer cells. This is a multi-center, open-label, Phase I/II study of obatoclax administered in combination with docetaxel in 3-week cycles to patients with relapsed or refractory Non-Small Cell Lung Cancer. Treatment may be administered on an outpatient basis. No investigation or commercial agents or therapies other than those described herein may be administered with the intent to treat the patient's malignancy. Supportive care measures

2006 Clinical Trials

15628. Molecular Analysis of Patients With Neuromuscular Disease

patients and their families by providing accurate diagnosis, presymptomatic and/or prenatal testing. Genotype-phenotype correlation studies have increased our understanding of the natural history of these rare disorders benefiting patients through better prognostic determinations by clinicians. Biochemical and pathological analysis of muscle biopsies in patients with known and unknown types of neuromuscular disease has led to new insights into disease pathophysiology, which we hope will aid in finding (...) Collaborator: National Institute of Neurological Disorders and Stroke (NINDS) Information provided by (Responsible Party): Louis Kunkel, Boston Children’s Hospital Study Details Study Description Go to Brief Summary: The purpose of this study is to identify genes and proteins responsible for nerve and muscle disorders by studying genetic material from individuals with neuromuscular disease, as well as their family members. We are interested in recruiting many types of neuromuscular disease including

2006 Clinical Trials

15629. Simultaneous Integrated Boost (SIB)- IMRT

therapeutic indexes. Modification of dose fractionation schedules can improve the therapeutic outcome by using accelerated or hyperfractionated regimes [Ang, 1990; Ang, 1998; Fu, 2000; Gwozdz, 1997]. Intensity Modulated Radiation Therapy (IMRT) technique allows the planning and irradiation of different targets at different dose levels in a single treatment session, instead of successive treatment plans. With conventional 2D radiotherapy, both normal tissues and tumors are irradiated with a similar dose (...) that is achievable with IMRT makes it possible to envisage an increase in physical dose while still maintaining the dose to the OAR at a reasonable level, several options could be considered to attain this objective. In simultaneous accelerated radiation therapy (SMART) boost technique initially described by Butler, large fractions of 2.4 Gy were delivered to the primary Planning Target Volume (PTV) associated with the primary tumor GTV, while conventional fractions of 2 Gy were delivered to the secondary PTV

2006 Clinical Trials

15630. The Role of P-cresol and Related Protein Fermentation Metabolites in Chronic Kidney Disease Patients

Sponsor: Universitaire Ziekenhuizen Leuven Information provided by (Responsible Party): Björn Meijers, Universitaire Ziekenhuizen Leuven Study Details Study Description Go to Brief Summary: Study on the natural history of uremic retention solutes in patients with mild-to-moderate chronic kidney disease Condition or disease Intervention/treatment Chronic Kidney Disease Behavioral: observational Detailed Description: Protein-bound uremic retention solutes are increasingly recognized to play a role (...) of protein-bound uremic retention solutes Outcome Measures Go to Biospecimen Retention: Samples Without DNA Serum, plasma Urine (if provided by patient) 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

2007 Clinical Trials

15631. Zactima With Temodar During Radiation Treatment for Newly Diagnosed Stage IV Brain Tumors

for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest. Followed by the "Maintenance" Phase: 12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2 (...) ) of a 28-day TMZ cycle. If 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given. This is given for 12 cycles. Other Name: Temodar Radiation: Radiation Therapy Radiotherapy must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy. Other Names: RT XRT Experimental

2007 Clinical Trials

15632. A Study To Assess The Efficacy And Safety Of Dutasteride 0.5mg Once Daily For 6 Months In The Treatment Of Male Subjects With Androgenetic Alopecia

. 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 49 Years (Adult) Sexes Eligible for Study: Male Accepts Healthy Volunteers: No Criteria Inclusion criteria: Rationale - The vertex area of the scalp will be evaluated during this study (...) or any other condition or disease of the scalp or hair, including diseases of the hair shaft (e.g., uncontrolled seborrheic dermatitis, tinea infections, other causes of alopecia, prior hair transplants or scalp reductions, psoriatic dermatitis) and inability to discontinue use of hair weaving. Subjects who use hair colourants/hair dyes, or have the remaining traces of colourants in their hair. Subjects must maintain their natural hair colour throughout the study. Hair length in non-balding areas

2007 Clinical Trials

15633. Prospective Clinical Study of the Guidant Microwave Ablation System for the Treatment of PAF in the MIS Procedure

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 Criteria Inclusion Criteria: Patient is greater than or = 18 years of age Patient has documented symptomatic paroxysmal (...) -lead electrocardiogram [ECG], Holter monitor, event monitor, or other telemetry rhythm strip) with the presence of sinus rhythm and/or underlying rhythm between episodes. Patient has been informed of the nature of the study, agreed to its provisions, and provided written informed consent. Exclusion Criteria: Patient had a cerebral vascular accident or transient ischemic attack within the previous 6 months. Patient had a myocardial infarction within the previous 6 weeks. Patient has underlying

2006 Clinical Trials

15634. Pemetrexed Plus Cisplatin as First-Line Treatment in Stage IV or Recurrence of Gastric Cancer

Posted : August 17, 2010 Sponsor: Eli Lilly and Company Information provided by: Eli Lilly and Company Study Details Study Description Go to Brief Summary: Study H3E-MW- S108 is a multicenter, single arm, open-label Phase 2 study to determine the response rate of pemetrexed plus cisplatin in patients with Stage IV gastric cancer, not amenable to curative surgery, or recurrence after prior surgery, who have had no prior chemotherapy. It was planned to enroll approximately 50 patients who qualified (...) . A grading (severity) scale is provided for each event term. Grades range from 0 (none) to 5 (death). Number of Participants Who Died During the Study [ Time Frame: During study drug therapy up to six or eight 21-day cycles or treatment; maximum duration of study follow-up was 17.4 months ] 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

2006 Clinical Trials

15635. Manual Physical Therapy and Exercise for Mechanical Neck Disorders

that included each patient’s age; gender; medication use; imaging results; and the location, nature, and duration of symptoms. Self-report measures included the NDI and VAS pain scales. Physical exam measures included cervical range of motion measurements with a gravity inclinometer, passive accessory motion testing to assess cervical spine segmental mobility and pain provocation, an upper quarter neurological screening, and special tests commonly used to identify cervical impairments. Participants meeting (...) that are commonly referenced and used in clinical practice. We provided all patients in the MTE group with a standard home exercise program of cervical retraction, deep neck flexor strengthening, and cervical rotation range of motion exercises. Patients in the MI group received a basic treatment plan consistent with general practitioner care. We provided all patients with a basic regimen of postural advice, encouragement to maintain neck motion and daily activity levels, cervical rotation range of motion

2006 Clinical Trials

15636. Phase II Capecitabine, Oxaliplatin & Bevacizumab for Metastatic / Unresectable Neuroendocrine Tumors

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: Subjects must be treated (...) not require separate histological or cytological confirmation of metastatic disease unless an interval of > 5 years has elapsed between the primary surgery and the development of metastatic disease. Clinicians should consider biopsy of lesions to establish diagnosis of metastatic disease if there is substantial clinical ambiguity regarding the nature or source of apparent metastases. Prior chemotherapy will be permitted, although the patient may not have had prior oxaliplatin. Patients must have a primary

2006 Clinical Trials

15637. Radiation Therapy Outreach Program for Minority or Low-Income Patients With Newly Diagnosed Cancer

and nature of post-diagnosis surgery or biopsy [ Time Frame: Observation ] Proportion of patients compliant with treatment plan [ Time Frame: Observation ] Total radiation dosage per patient (curative and palliative endpoints) [ Time Frame: Observation ] Supportive services provided to patients [ Time Frame: Observation ] Rate of treatment completion [ Time Frame: Observation ] Accrual for clinical research protocols [ Time Frame: Observation ] Retention in clinical research protocols [ Time Frame (...) to identify specific needs, in terms of receiving cancer care. The interview serves as a basis for developing a plan to assist patients through treatment and follow up. The Patient Navigator meets the patient, in person or over the phone, at various times during treatment to help the patient overcome barriers to completion of cancer therapy. The Patient Navigator then provides yearly follow up to facilitate continued medical follow up. Patients complete surveys before and after program participation

2006 Clinical Trials

15638. OatMeal and Insulin Resistance: OMA-IR

as after the four week outpatient period (Lammert et al. 2006). The most important shortcomings of this study were the hypocaloric interventions in both groups (diabetes-adapted diet: 1500kcal/d vs. oatmeal 1200kcal/d) making it difficult to attribute the observed effects to oatmeal alone as well as the uncontrolled nature. These design flaws have been addressed within this new clinical trial. The investigators plan an open label, cross-over study with isocaloric interventions (oatmeal and diabetes (...) as 4, 8, 12, and 16 weeks after intervention ] c-reactive protein, prostaglandin F2 alpha, cholesterol, HDL and LDL. [ Time Frame: directly before and after intervention as well as 4, 8, 12, and 16 weeks after intervention ] 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

2006 Clinical Trials

15639. Interpersonal Psychotherapy for Depressed Adolescents Engaging in Non-suicidal Self-injury

for co-morbid depression and self-injury, although adaptations to the protocol will likely be needed to address the behavioral aspect of the self-injury. Data analyses will be descriptive in nature and involve examining the individual trajectories of depression and NSSI over time. The data obtained from the current study will lay the groundwork for an ultimate randomized controlled trial in which we plan to compare IPT-A versus nondirective supportive therapy in the treatment of co-morbid depression (...) Frame: 8 weeks ] Self-injury Monitoring Card [ Time Frame: 1 month ] Secondary Outcome Measures : Beck Depression Inventory [ Time Frame: 2 weeks ] Multidimensional Anxiety Scale for Children [ Time Frame: recently ] 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

2006 Clinical Trials

15640. A Study of the Drug Casopitant for the Prevention of Nausea Caused By Cisplatin-Based Highly Emetogenic Chemotherapy

respiratory rate is presented. Summary of mean heart rate [ Time Frame: Up to end of cycle (approximately 28 days per cycle); maximum up to 24 months ] It was assessed on Day 1, during day 6-10 and end of cycle in cycle 1 while on Day 1and end of cycle in subsequent cycles 2 to 6. Summary of mean heart rate is presented. 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 Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion criteria: Subject understands the nature and purpose of this study and the study procedures and has signed an informed consent form

2007 Clinical Trials

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