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Stimulant Use Disorder

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30661. Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to People With CD70 Expressing Cancers

of their tumor and the treatment s impact. Condition or disease Intervention/treatment Phase Pancreatic Cancer Renal Cell Cancer Breast Cancer Melanoma Ovarian Cancer Drug: Cyclophosphamide Drug: Fludarabine Drug: Aldesleukin Biological: Anti-hCD70 CAR transduced PBL Phase 1 Phase 2 Detailed Description: Background: We generated a chimeric antigen receptor (CAR) that engages CD70 using its natural ligand CD27, as the binding moiety. Transducing peripheral blood lymphocytes (PBL) with this CAR conveys major (...) -infective treatment, coagulation disorders, or any other active or uncompensated major medical illnesses. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease). History of major organ autoimmune disease. Concurrent opportunistic infections (The experimental treatment being evaluated in this protocol depends on an intact immune system. Patients who have decreased immune-competence may be less responsive to the experimental treatment and more susceptible to its toxicities

2016 Clinical Trials

30662. Clinical Trial on Efficacy of rTMS to Improve ECT in Treatment-Resistant Depression

the augmentation of Electroconvulsive therapy (ECT) by repeated Transcranial Magnetic Stimulation (rTMS). The primary outcome will be the depressive symptoms intensity measured with the Hamilton Rating Scale For Depression (HAMD-21 items) after 5 ECT. The secondary outcome is to evaluate the safety and most particularly the cognitive effects of this association. Condition or disease Intervention/treatment Phase Major Depressive Disorder Device: active rTMS-ECT Device: sham rTMS-ECT Not Applicable Detailed (...) Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Patients with Major Depressive Disorder (HAMD≥15) Level of resistance ≥ 3 (Thase and Rush) Participants who gave their informed, written consent Exclusion Criteria: Contraindication of Electroconvulsive therapy (ECT), repeated Transcranial Magnetic Stimulation (rTMS), Magnetic Resonance Imaging (MRI), anesthesia History of epilepsy; severe neurological or systemic disorder that could significantly affect cognition

2016 Clinical Trials

30663. Psychometric Measurements of Three Nociception Assessments Methods in Intubated Brain Injured Critical Care Patients

adapted for intubated patients (NCS-I) in comparison with the recommended scale (BPS) and the Pupillary response (videopupillometry) to noxious stimulation (common procedure of care). Condition or disease Intervention/treatment Intubated Brain Injured Other: NCS-I (Nociception Coma Scale adapted intubated patients) Detailed Description: Nociception in intensive care unit is frequently evaluated with some tools such as BPS (Behavioral Pain scale) and NCS (Nociception coma scale). These scales were (...) not validated in intubated and brain injured ICU patients. The investigators propose to validate the NCS adapted for intubated patients (NCS-I) in comparison with the recommended scale (BPS) and the Pupillary response (videopupillometry) to noxious stimulation (common procedure of care). Study Design Go to Layout table for study information Study Type : Observational Actual Enrollment : 50 participants Observational Model: Other Time Perspective: Prospective Official Title: Psychometric Measurements

2016 Clinical Trials

30664. Study to Assess Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of RO7112689 in Healthy Volunteers and Participants With Paroxysmal Nocturnal Hemoglobinuria

, in the investigator's opinion, benefit from treatment with RO7112689 All Parts: Male and female participants should use proper means of contraception Exclusion Criteria: Part 1 (HVs only): Any clinically relevant history or the presence of moderate to severe respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, or connective tissue disease Any major illness within 1 month before the screening History of clinically significant (...) the results of the study or that poses an additional risk to the participant by his or her participation in the study History of bone marrow transplantation Treatment with azathioprine or erythrocyte-stimulating agents within 14 days prior to first study drug administration Part 3 - PNH patients only: Any evidence of sero-positive auto-immune connective tissue diseases (such as systemic lupus erythematosus, or rheumatoid arthritis) Any evidence of active inflammatory conditions (including inflammatory

2016 Clinical Trials

30665. Clinical and Basic Research of ETV Plus GM-CSF in Chronic Hepatitis B Patients

of entecavir (ETV) plus GM-CSF in patients with CHB compared to ETV monotherapy. Condition or disease Intervention/treatment Phase Hepatitis B, Chronic Drug: Granulocyte Macrophage-colony Stimulating Factor Drug: Entecavir Not Applicable Detailed Description: Antiviral treatment plays critical role in treatment of chronic HBV infection. Entecavir, an nucleos(t)ide analogs (NA) targeting the viral polymerase, is widely used in China as the first line drug in antiviral treatment for CHB patients (...) . The sustained suppression of serum HBV DNA to undetectable level has been proven to be associated with the prevention of progression of liver disease and inhibition of the development of hepatocellular carcinoma. According to data published, a rate about 70% HBVDNA undetectable could be reached after 1 year therapy. However, the rate of HBsAg loss is very low about 0% to 1%. Granulocyte-macrophage colony-stimulating factor(GM-CSF) is an important cytokine for the generation and propagation of antigen

2016 Clinical Trials

30666. 68Ga-NODAGA-exendin-4 PET/CT for Diagnostic Imaging in AHH

of IPPNET in AHH patients. Since pre-operative localization of foci in AHH remains challenging and frequently still leading to futile surgery or unnecessary partial pancreatectomy, a more sensitive and specific imaging technique would be of great value. Condition or disease Intervention/treatment Phase Insulinoma Radiation: 68Ga-NODAGA-exendin 4 PET/CT Phase 1 Phase 2 Detailed Description: Adult endogenous hyperinsulinaemic hypoglycaemia The most common form of functional neuroendocrine tumours (...) morbidity by helping to optimize the surgical procedure. Successful preoperative localization of IPPNET is a challenging problem since approximately 30% of IPPNET cannot be visualized using the conventional imaging techniques CT and/or MRI and endoscopic ultrasound. Selective arterial stimulation with calcium with simultaneous venous sampling (ASVS) has been described to have a sensitivity and specificity of almost 90% in identifying IPPNET. This is, however, an invasive technique which is accompanied

2016 Clinical Trials

30667. The Value of Progesterone for the Timing of the Embryo Transfer in IVF/ICSI: a Prospective Randomised Trial

of the hCG injection, they will be randomised. One group of patients will have a fresh embryo transfer, in the second group all embryos will be cryopreserved and transfered in a subsequent (natural or artificial) cycle. The aim of this study is to compare clinical pregnancy rate between the two groups. Condition or disease Intervention/treatment Phase Clinical Pregnancy Rate Procedure: Freeze all Not Applicable Study Design Go to Layout table for study information Study Type : Interventional (Clinical (...) Healthy Volunteers: Yes Criteria Inclusion Criteria: IVF/ICSI treatment progesterone > 1 ng/ml and ≤ 1.5 ng/ml Exclusion Criteria: > 40 years AMH ≤ 1 ng/ml Conditions influencing pregnancy rate (e.g. hydrosalphinx, uterus malformation, hyperprolactinemia and other endocrine conditions; with the exception of controlled thyroid function disease) no available progesterone value on the day of hCG-injection Contacts and Locations Go to Information from the National Library of Medicine To learn more about

2016 Clinical Trials

30668. Influence of the Aquatic Physical Activity for the Neurologic Development of the Babies

in the aquatic physical activity programme in a heated pool (34-35ºC) and a control group with 71 babies who will not participate in the activities. The aquatic activity will consist on 20 minutes sessions twice a week. Condition or disease Intervention/treatment Phase Infant Behavior Gestational Age Over 30 Weeks Behavioral: Aquatic physical activity in babies Not Applicable Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 145 (...) therapeutic safety in the water is very broad, which allows an optimal development of aquatic early stimulation programs. Objective: To determine the relationship between aquatic physical activity in infants and the development of their psychomotor skills in their first year. Methods: A prospective case-control study will take place for 12 months. Participating infants will be divided in two groups: an experimental group, which will be integrated by 74 babies who will participate with their parents

2016 Clinical Trials

30669. Platinum and Polyadenosine 5'Diphosphoribose Polymerisation (PARP) Inhibitor for Neoadjuvant Treatment of Triple Negative Breast Cancer (TNBC) and/or Germline BRCA (gBRCA) Positive Breast Cancer

by (Responsible Party): Jean Abraham, University of Cambridge Study Details Study Description Go to Brief Summary: This neoadjuvant trial for patients with TNBC and/or gBRCA breast cancer, aims to investigate the safety and efficacy (improvement in pathological Complete Response at surgery) of concurrent platinum-based chemotherapy with olaparib an inhibitor of the PARP enzyme (PARPi). Condition or disease Intervention/treatment Phase Breast Cancer Drug: Olaparib Drug: Paclitaxel and Carboplatin Phase 2 Phase (...) on safety grounds: Severe toxicity or inter-current illness, requiring cessation in the judgement of patient's clinician. Patient within 4 weeks has not recovered from toxicity to an extent that allows further treatment. Patient unable to comply with trial procedures. Disease progression while on trial treatment. Patient becomes pregnant. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 527 participants Allocation: Randomized

2016 Clinical Trials

30670. Abdominal Massage for Bowel Dysfunction

hernia, rectal prolapse, Inflammatory Bowel Disease, pregnancy and past history of volvulus. Recent abdominal scars, abdominal wounds or skin disorders that may make abdominal massage uncomfortable. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its identifier (NCT number (...) of the AMBER trial is to determine the effectiveness and cost effectiveness of abdominal massage as part of the adjunct to bowel care in people with Multiple Sclerosis who have problems with their bowel i.e. faecal incontinence and/or constipation. Condition or disease Intervention/treatment Phase Multiple Sclerosis Behavioral: Abdominal massage Behavioral: Optimised bowel care Not Applicable Detailed Description: Neurogenic bowel dysfunction (NBD: constipation and/or faecal incontinence) is common

2016 Clinical Trials

30671. Light Irradiation and Outcome for Neuropathic Pain

outcoms are measured before and after SGI in each session. All measures at the first-half and second-half courses are analyzed. Condition or disease Intervention/treatment Phase Complex Regional Pain Syndrome Other: Linearly Polarized Near-Infrared light Irradiation Not Applicable Detailed Description: Sympathetically maintained pain (SMP) is defined as an aspect of pain which is maintained or mediated by sympathetic efferent activity including the action of circulating catecholamine and is often (...) will be recruited from the chronic pain center at our hospital. Exclusion Criteria: Patients who meted the following criteria are excluded: Diagnosis of glioblastoma, History of heart disease, serious arrhythmia or pacemaker user, Simmond disease or postpartum hypopituitarism, Habitual smoking or consumption of stimulant beverages such as tea, coffee, or alcohol, and Any other condition that is unsuitable for phototherapy by a doctor's evaluation. Contacts and Locations Go to Information from the National

2016 Clinical Trials

30672. Effectiveness of Two Stretching Techniques on Healthy Volunteers With Shortened Hamstrings

extensibility. Condition or disease Intervention/treatment Phase Muscle Tone Abnormalities Procedure: Neuromuscular Electrical Elongation Procedure: Proprioceptive Neuromuscular Facilitation Not Applicable Detailed Description: It is a double-blinded randomized clinical trial where subjects are healthy volunteers from the city of Zaragoza older than 18 years. All subjects will be injury free at the time of the study and must not have a history of knee or hip surgery. They must be physically active (...) will be performed on the subjects. For hamstrings extensibility: Active-Knee-Extension Test (AKE) results will bring information of the knee extension range of motion. Straight-Leg-Raise Test (SLR) results will bring information of the hip flexion range of motion. For quadriceps extensibility: Goniometric measure of knee flexion. Distance from heel to gluteus using a tape measure. Viscoelasticity properties of hamstrings and quadriceps muscles: - Myotonometric measurement using a myotonometer to obtain

2016 Clinical Trials

30673. Effects of Recombinant LH in Patients With Repeated Implantation Failure

recombinant human luteinizing hormone (r-hLH) is less clear. Aim of the present study is to evaluate If adding rLH in the late phase of stimulation can benefit in some patient awith repeated implantation failure. Condition or disease Intervention/treatment Phase Female Infertility Female Subfertility Drug: rFSH + r-LH in combination Drug: rFSH alone Not Applicable Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 60 participants (...) as the standard protocol during the last two decades, but the use of GnRH antagonists offers the opportunity to control the endogenous LH surge in a rapid and more convenient way. LH plays a key role in the intermediate-late phases of folliculogenesis. The presence of receptors for LH in cumulus granulosa cells and its correlation with oocyte maturation has been demonstrated. Although ovarian stimulation is efficiently achieved in most cases by the administration of exogenous FSH alone, specific subgroups

2016 Clinical Trials

30674. Interlimb Transfer Post-stroke

development of this approach for clinical implementation. Condition or disease Intervention/treatment Stroke Other: submaximal exercise (grip) Detailed Description: The long-term goal is to restore upper extremity (UE) motor function following stroke. The overall objective of this proposal is to improve the investigators' understanding of neural mechanisms contributing to inter-limb and inter-hemispheric transfer following non-paretic limb exercise to task failure. The investigators will use transcranial (...) magnetic stimulation to probe acute adaptations in cortical excitability, intracortical and inter-hemispheric circuits that accompany behavioral facilitation of the paretic hand. The work proposed in this two year project will enable the investigators to obtain three data elements critical to complete the working hypothesis: . Changes in intracortical and interhemispheric inhibition in both hemispheres following non-paretic limb exercise to task-failure. . Behavioral effects using a motor task

2016 Clinical Trials

30675. CKD-841 Pharmacokinetic/Pharmacodynamic Study

Description Go to Brief Summary: A randomized, open-label, single dose, parallel design phase I clinical trial to investigate the safety and pharmacokinetic/pharmacodynamics of CKD-841 or Leuplin Inj. 3.75mg after subcutaneous injection in postmenopausal female. Condition or disease Intervention/treatment Phase Postmenopausal Disorder Drug: LeuplinⓡInj Drug: CKD-841 Phase 1 Detailed Description: To investigate the safety and pharmacokinetic/pharmacodynamics of CKD-841 or Leuplinⓡ Inj. 3.75mg after (...) , Older Adult) Sexes Eligible for Study: Female Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Healthy menopausal female β-hCG is negative at screening and before administration of investigational drug Infertility by sterilization operation before 5 months from screening excluding ovarian cancer, uterine cancer etc... Bwt ≥ 50Kg and Body Mass Index (BMI) ≥ 18.5 and < 25 Exclusion Criteria: History or current condition of disease related to Hepato-biliary system, renal system, nervous

2016 Clinical Trials

30676. Transcranial Alternating Current for Oscillopathies

application in day-to-day practice for the benefit of people with the target conditions. The patient-groups, after undergoing the neurophysiology studies, will be tested with disease-specific scales and a neuropsychological battery. A 2-weeks tACS, either real or active sham, protocol will then be performed (30 minutes/day, 5 days/week), associated with an ad hoc rehabilitation protocol (60 minutes/day 5 days/week). During the last day of stimulation, patients will be tested again with the disease (...) specific scales, neuropsychological battery and standard EEG to detect EEG frequencies modifications. At 4-weeks follow up, the same tests and EEG recording will be carried out, to assess the persistence of after-effects. The expected result is a valid, non-invasive and cost-effective stimulation paradigm based on sound neurophysiologic markers which transcend traditional disease classifications. Condition or disease Intervention/treatment Phase Parkinson Disease Pain Device: transcranial alternating

2016 Clinical Trials

30677. Third-generation CD28/4-1BB chimeric antigen receptor T cells for chemotherapy relapsed or refractory acute lymphoblastic leukaemia: a non-randomised, open-label phase I trial protocol. Full Text available with Trip Pro

transgene and plasma cytokines will be assayed for 2 years after CAR-T infusion using flow cytometry, real-time quantitative PCR and cytometric bead array, respectively. Moreover, several predictive plasma cytokines including interferon-γ, interleukin (IL)-6, IL-8, Soluble Interleukin (sIL)-2R-α, solubleglycoprotein (sgp)130, sIL-6R, Monocyte chemoattractant protein (MCP1), Macrophage inflammatory protein (MIP1)-α, MIP1-β and Granulocyte-macrophage colony-stimulating factor (GM-CSF), which are highly (...) associated with severe cytokine release syndrome (CRS), will be used to forecast CRS to allow doing earlier intervention, and CRS will be managed based on a revised CRS grading system. In addition, patients with grade 3 or 4 neurotoxicities or persistent B-cell aplasia will be treated with dexamethasone (10 mg intravenously every 6 hours) or IgG, respectively. Descriptive and analytical analyses will be performed.Ethical approval for the study was granted on 10 July 2014 (YLJS-2014-7-10). Written

2016 BMJ open

30678. Innovations in Functional Neurosurgery and Anesthetic Implications. (Abstract)

Innovations in Functional Neurosurgery and Anesthetic Implications. Functional neurosurgery has undergone rapid growth over the last few years fueled by advances in imaging technology and novel treatment modalities. These advances have led to new surgical treatments using minimally invasive and precise techniques for conditions such as Parkinson's disease, essential tremor, epilepsy, and psychiatric disorders. Understanding the goals and technological issues of these procedures is imperative (...) for the anesthesiologist to ensure safe management of patients presenting for functional neurosurgical procedures. In this review, we discuss the advances in neurosurgical techniques for deep brain stimulation, focused ultrasound and minimally invasive laser-based treatment of refractory epilepsy and provide a guideline for anesthesiologists caring for patients undergoing these procedures.

2016 Journal of neurosurgical anesthesiology

30679. Purified human skeletal muscle-derived stem cells enhance the repair and regeneration in the damaged urethra. Full Text available with Trip Pro

from the human skeletal muscle, sorted using flow cytometry as CD34/45 (Sk-34) and CD29/34/45 (Sk-DN/29) fractions, and separately cultured/expanded in appropriate conditions within 2 weeks. Urethral damage was induced by manually removing one third of the wall of the muscle layer in nude rats. A mixture of expanded Sk-34 and Sk-DN/29 cells was applied on the damaged portion for the cell transplantation (CT) group. The same amount of media was used for the non-CT (NT) group. Urethral pressure (...) profile was evaluated via electrical stimulation to assess functional recovery. Cell engraftments and differentiations were detected using immunohistochemistry and immunoelectron microscopy. Expression of angiogenic cytokines was also analyzed using reverse transcriptase-polymerase chain reaction and protein array.At 6 weeks after transplantation, the CT group showed a significantly higher functional recovery than the NT group (70.2% and 39.1%, respectively; P < 0.05). Histological analysis revealed

2016 Transplantation

30680. Spasmogenic and spasmolytic activities of Agastache mexicana ssp. mexicana and A. mexicana ssp. xolocotziana methanolic extracts on the guinea pig ileum. (Abstract)

Spasmogenic and spasmolytic activities of Agastache mexicana ssp. mexicana and A. mexicana ssp. xolocotziana methanolic extracts on the guinea pig ileum. Agastache mexicana has been used in traditional medicine for relief of abdominal pain and treatment of other diseases. Two subspecies have been identified: A. mexicana ssp. mexicana (AMM) and A. mexicana ssp. xolocotziana (AMX) and both are used traditionally without distinction or in combination.To determine the effect of methanol extracts (...) of the traditional use of Agastache mexicana in relieving gastrointestinal disorders, but indicate that the subspecie that should be used for this effect is A. mexicana ssp. xolocotziana.Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

2016 Journal of Ethnopharmacology

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