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You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma <BriefSummary:>This phase II trial studies how well trabectedin and olaparib work in treating patients with sarcoma that cannot be removed by surgery or has spread to other places in the body. Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing cells, stopping them from dividing or stopping them from spreading. Olaparib may stop the growth of tumor cells by blocking pathways responsible for repairing damaged cells. Giving trabectedin and olaparib may shrink or stop the tumor from growing. <EligibilityCriteria:>Key Inclusion Criteria
* Age ≥ 16 years
* Advanced unresectable or metastatic sarcoma
* Cohort 1: Leiomyosarcoma (LMS)/Liposarcoma (LPS)
* Cohort 2: Other sarcoma histologies (excluding gastrointestinal stromal tumors)
* Received at least 1 prior standard chemotherapy. For cohort 1 patients, this must have included a prior anthracycline.
* Measurable disease by RECIST 1.1
* Adequate hematologic, renal, hepatic function
* Adequate creatine phosphokinase
* ECOG performance status ≤ 1
* Left ventricular ejection fraction (LVEF) \>= institutional lower limit of normal (LLN)
* Women of childbearing potential and men must agree to use adequate contraception from signing informed consent to at least 6 months (females) and 5 months (men) after study drug treatment
Key Exclusion Criteria
* Prior therapy with PARP inhibitor, including olaparib
* Prior therapy with trabectedin
* Additional active malignancy or treatment for alternative cancer (excluding non-melanoma skin cancer) requiring treatment within the past two years
* Pregnant or breastfeeding women
* Known hypersensitivity to trabectedin or olaparib
* Other exclusions per protocol <Conditions:>Sarcoma, Sarcoma Metastatic <Interventions:>Olaparib, Trabectedin | 'Age, Categorical', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Endotracheal Tube Intracuff Pressure and Leak <BriefSummary:>We have devised a simple method to continuously measure the endotracheal tube cuff pressure (CP) using an invasive pressure monitoring setup (IPMS), which is used routinely in the operating room to monitor arterial or central venous pressures. We have previously confirmed both in vitro and in vivo (previous IRB approved protocol), a clinically applicable agreement of the IPMS readings with the values obtained from a standard manometer (gold standard). In the current study, we will prospectively evaluate the relationship between the patient's head position and CP in patients undergoing otolaryngological surgery. A secondary outcome measure is the oxygen or nitrous oxygen concentration in the oropharynx. <EligibilityCriteria:>Inclusion Criteria:
* Less than 18 years of age, undergoing otolaryngological surgery with endotracheal intubation.
Exclusion Criteria:
* Patient who is intubated with an uncuffed endotracheal tube.
* Patients who have a limitation for movement of the neck or concerns of the stability of the cervical spine. <Conditions:>Otolaryngological Surgery <Interventions:>Cuffed ETT | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Amlodipine Versus Nifedipine ER for the Management of Postpartum Hypertension <BriefSummary:>A significant number of pregnancies are complicated by hypertensive disorders. Hypertension often worsens in the postpartum period and many women need started on medications. Currently, recommended medications for blood pressure management in pregnant and postpartum women are limited, with labetalol and nifedipine ER being the most commonly used medications. While these medications are both effective, they are not without limitations. Amlodipine is a medication in the same class as nifedipine ER. It is a first-line antihypertensive in the general population. It tends to have less side effects than nifedipine ER. It has not been studied specifically in postpartum women. The purpose of this study is to determine if amlodipine is noninferior to nifedipine ER in managing hypertension in the postpartum period. <EligibilityCriteria:>Inclusion Criteria:
* Postpartum women with a diagnosis of chronic hypertension, gestational hypertension, or preeclampsia
* Delivery at or beyond 20 weeks' gestation
* Need for antihypertensive therapy, defined as blood pressure \>/= 150 mmHg systolic and/or 100 mmHg diastolic on two occasions four hours apart or isolated blood pressure \>160/110 mmHg
* English or Spanish-speaking
* Age 18 years or older
Exclusion Criteria:
* Use of antihypertensive prior to delivery (for any indication)
* Allergy to nifedipine ER or amlodipine
* Persistent tachycardia (as defined by the treatment team) <Conditions:>Hypertension in Pregnancy <Interventions:>Amlodipine, NIFEdipine ER | 'Age, Continuous', 'Sex: Female, Male', 'Race and Ethnicity Not Collected', 'Region of Enrollment', 'BMI at delivery', 'Parity', 'Gestational age at delivery', 'Mode of delivery', 'Hypertensive diagnosis', 'Diabetes' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Randomized Conversion of Calcineurin-Inhibitors in Renal Allograft Recipients <BriefSummary:>This study is being done to investigate the impact of changing immunosuppressive medications from tacrolimus (Prograf®) to sirolimus (Rapamune®) between 6 and 24 months post transplant. The primary purpose of this research study is to evaluate whether the use of mycophenolate mofetil(MMF)/Cellcept® and tacrolimus(TAC)/Prograf® (Group 1) or mycophenolate mofetil(MMF)/Cellcept® and sirolimus/Rapamune® (Group 2) impacts the incidence of acute cellular rejection in post kidney transplant patients. This study will examine whether switching from tacrolimus to sirolimus will better preserve long-term kidney function. <EligibilityCriteria:>Inclusion Criteria:
1. Subjects should be adults ≥ 18- ≤ 70 years of age
2. Subjects can be either gender or of any ethnic background
3. Subjects should be single organ recipients (kidney only)
4. Subjects must be able to understand the protocol and provide informed consent.
Exclusion Criteria:
1. Subjects with end-stage renal disease (ESRD) secondary to primary focal segmental glomerulonephritis (FSGS).
2. Inability to comply with study procedures
3. Inability to sign the informed consent
4. Subjects with a significant or active infection
5. Subjects who are pregnant or nursing females
6. Subjects with a history of severe hyperlipidemia not controlled with statins, patients with at total cholesterol of \> 400 mg/dl
7. Subjects with a platelet count \<100,000mm3 white blood cell (WBC)\< 2,000mm3
8. Subjects with severe proteinuria at the time of randomization (\>2gm/day)
9. Subjects with more then 2 episodes of acute cellular rejection post transplantation will be excluded from this study
10. An estimated GFR\<40 cc/min
11. A history of malignancy during the post-transplant period (other than treated basal cell cancer and/or squamous cell cancer)
12. Subjects, who, due to the existence of a surgical, medical or psychiatric condition, other than the current transplant, which in the opinion of the investigator, precludes enrollment into this trial
13. A history of albumin-creatinine ratio (ACR) during the most recent previous 3 months prior to randomization <Conditions:>Renal Transplant Rejection <Interventions:>Sirolimus, Demographic Data, Medical History, and Donor Data, Blood Draws for Control Group, Blood Draws for Experimental Group, Donor Blood Draws, Donor Information, Kidney Biopsy | 'Age, Customized', 'Sex/Gender, Customized', 'Race/Ethnicity, Customized', 'Region of Enrollment', 'HLA mismatch', 'Donor type', 'PRA >20%', 'Diabetis mellitus', 'Elevated blood pressure', 'Coronary artery disease (CAD)', 'Smoking' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Secukinumab Efficacy and Safety Study in Patients With Rheumatoid Arthritis and Inadequate Response to Anti-TNFα Agents. <BriefSummary:>This study will provide efficacy and safety data of the secukinumab pre-filled syringe (PFS) for subcutaneous self-administration in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents. <EligibilityCriteria:>Inclusion Criteria: • Presence of Rheumatoid Arthritis classified by ACR 2010 revised criteria for at least 3 months •Disease activity defined by ≥6 tender joints out of 68 and ≥ 6 swollen joints out of 66 at baseline and with: Either Anti-CCP antibodies positive OR Rheumatoid Factor positive AND WITH Either hsCRP ≥ 10 mg/L OR ESR ≥28 mm/1st hr •Intake of at least one anti-TNF-α agent such as etanercept, adalimumab, infliximab, certolizumab or golimumab for at least 3 months before entering the study and to have experienced an inadequate response to treatment or to have been intolerant to at least one administration Exclusion Criteria:
* Current RA functional status class IV according to the ACR 1991 revised criteria •Previous use of secukinumab or other biologic drug directly targeting IL-17 or IL-17 receptor and/or any history of hypersensitivity to secukinumab or its excipient or to drugs of similar chemical classes. Other protocol-defined inclusion/exclusion criteria may apply <Conditions:>Rheumatoid Arthritis <Interventions:>Secukinumab (AIN457), Placebo | 'Age, Categorical', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Clinical Evaluation of Systane® Balance in Dry Eye Subjects <BriefSummary:>The purpose of this study is to evaluate the efficacy and safety of Systane® Balance following 90 days of QID (4 times/day) dosing among Indian subjects with dry eye. <EligibilityCriteria:>Inclusion Criteria:
* Sign informed consent and willing and able to attend all study visits;
* Dry eye in both eyes diagnosed by an ophthalmologist;
* Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
* Women of childbearing potential who are pregnant or breastfeeding;
* Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in the study;
* Ocular surgery or ocular trauma requiring medical or pharmacological treatment within 1 year of Screening;
* Use of topical ocular prescription or non-prescription medications, RESTASIS or topical ocular steroids within 14 days of Screening;
* Use of any artificial tears/gels/lubricants/rewetting drops within 4 hours of Screening;
* Contact lens wear within 1 week of Screening and/or unwillingness to discontinue contact lens wear for the duration of the study;
* Other protocol-specified exclusion criteria may apply. <Conditions:>Dry Eye <Interventions:>Propylene Glycol 0.6% eye drops | 'Age, Categorical', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus <BriefSummary:>The purpose of this study is to determine the efficacy and safety of nasal glucagon compared to intramuscular (IM) glucagon for treatment of insulin-induced hypoglycemia in Japanese participants with diabetes mellitus. <EligibilityCriteria:>Inclusion Criteria:
* Participants with Type 1 diabetes (T1D) or Type 2 diabetes (T2D)
* Body mass Index (BMI) of 18.5 to 30.0 kilograms per meter squared (kg/m2) for T1D, or 18.5 to 35.0 kg/m2 for T2D
* Hemoglobin A1c (HbA1c) ≤10%
Exclusion Criteria:
* Have significant changes in insulin regimen and/ or unstable blood sugar control within the past 3 month
* Have received a total daily dose of insulin \>1.2 units per kilogram (U/kg) <Conditions:>Diabetes Mellitus <Interventions:>Glucagon Nasal Powder, Glucagon Hydrochloride Solution | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study of the Feasibility of Prehospital Remote Ischemic Conditioning <BriefSummary:>Prospective, single center, single arm pilot study evaluating the feasibility of delivering remote ischemic conditioning (RIC) by emergency medical services (EMS) in the prehospital setting. Eligible patients will have chest pain or anginal equivalent symptoms and require ground ambulance transport to the hospital. All subjects will undergo the standard RIC procedure (i.e., up to four cycles of alternating 5-min inflation and 5-min deflation) with the autoRIC® device (CellAegis Devices, Inc., Toronto, Ontario). The primary objective is to evaluate the number of cycles of RIC completed in patients having the procedure initiated by EMS in the prehospital setting. <EligibilityCriteria:>Inclusion Criteria:
1. Requiring 9-1-1 response to scene
2. At least 18 years of age
3. Experiencing non-traumatic chest pain or anginal equivalent symptom
4. Not meeting EMS criteria for a suspected STEMI based on prehospital ECG
5. Systolic blood pressure (SBP) between 100-180 mgm Hg
6. Designated for ambulance transport to University of North Carolina Medical Center (Chapel Hill, NC)
7. Capable of providing informed consent
Exclusion Criteria:
1. Unconscious or otherwise in critical condition
2. Lacking capacity to consent to the study
3. Non-English speaking
4. Pre-existing condition precluding blood pressure check or use of the autoRIC® at the discretion of the provider or listed here:
1. Paresis of upper limb
2. Pre-existing traumatic injury to arm
3. Presence of an arteriovenous shunt for dialysis
4. Prior mastectomy
5. Existing peripheral inserted central catheter line
6. Arm edema or other indication of upper extremity thrombosis
5. Serial ECG evidence of evolving STEMI <Conditions:>Chest Pain <Interventions:>autoRIC® device | 'Age, Categorical', 'Sex/Gender, Customized', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment', 'Systolic Blood Pressure (mmHg)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Evaluation of Opticell Ag on Split-Thickness Skin Graft Donor Sites in Adult Subjects <BriefSummary:>The purpose of this single center, prospective case series is to evaluate the effective management of split-thickness skin graft donor site wounds using Opticell Ag (Chitosan-based dressing). <EligibilityCriteria:>Inclusion Criteria:
* Inpatient status at study site
* Subject must be receiving a split-thickness skin graft (STSG)
* Wounds must not exceed 10% total body surface area (TBSA)
* Any donor site
* Ability to comply with necessary wound care/follow up
Exclusion Criteria:
* Subject is pregnant
* Subject has been diagnosed with Diabetes
* Subject is a smoker
* Subject takes steroids
* Subject is sensitive and/or allergic to shellfish and/or silver
* Wounds that exceed 10% total body surface area (TBSA)
* Inability to comply with necessary wound care/follow up <Conditions:>Split-thickness Skin Graft Donor Sites <Interventions:>Opticell Ag | 'Age, Categorical', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment', 'Allergies to chitosan/shellfish', 'Reason for split-thickness skin graft', 'Donor site area', 'Dermatome setting' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>BAX 326 (rFIX) Continuation Study <BriefSummary:>The purpose of this BAX 326 Continuation Study is to further investigate incremental recovery over time, the hemostatic efficacy, the safety, immunogenicity, and health-related quality of life (HR QoL) of BAX 326 in previously treated patients (PTPs) with severe and moderately severe hemophilia B who participated in BAX 326 pivotal study 250901 or BAX 326 pediatric study 251101. <EligibilityCriteria:>Main Inclusion Criteria:
* Subject and/or legal representative has/have voluntarily provided signed informed consent
* Subject has completed Baxter clinical study 250901 (pivotal study) or Baxter clinical study 251101 (pediatric study)
* Subject was 12 to 65 years old at the time of screening for Study 250901 or \< 12 years old at the time of screening for Study 251101
* Subject has severe (FIX level \< 1%) or moderately severe (FIX level 1-2%) hemophilia B (based on the one stage activated partial thromboplastin time (aPTT) assay), as tested at screening at the central laboratory
* Subject has not developed an inhibitory FIX antibody during Baxter Pivotal Study 250901 or Pediatric Study 251101
Main Exclusion Criteria:
* Subject received factor IX product(s) other than BAX 326 upon completion of Baxter Pivotal Study 250901 or Pediatric Study 251101
* Subject has been diagnosed with an acquired hemostatic defect other than hemophilia B
* For subjects transferring from Pivotal Study 250901: Subject's weight is \< 35 kg or \> 120 kg
* Subject is planned to take part in any other clinical study, with the exception of BAX 326 Surgery study as described in this protocol, during the course of the Continuation Study <Conditions:>Hemophilia B <Interventions:>BAX 326 (Recombinant factor IX) | 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>SBRT (Stereotactic Body Radiation Therapy) in Combination With Nivolumab/Ipilimumab in Renal Cell Carcinoma (RCC) / Kidney Cancer Patients <BriefSummary:>This is a multi-institution, single-arm phase II study to determine the safety and efficacy of SBRT (up to 2 metastatic sites preferentially lung, mediastinum or bone in combination of nivolumab and ipilimumab in patients with metastatic renal cell carcinoma(with a clear-cell component and at least 1 measurable metastatic lesion that is not being irradiated). <EligibilityCriteria:>Inclusion Criteria:
* Histological confirmation of RCC with a clear-cell component
* Metastatic (AJCC Stage IV) RCC
* Prior adjuvant or neoadjuvant therapy for localized or locally advanced RCC is allowed provided recurrence occurred = or \> 6 months after the last dose of the adjuvant or neoadjuvant therapy
* Any number of prior systemic treatment regimen in the advanced/metastatic setting is allowed (cytokine, anti-angiogenic, mammalian target of rapamycin (mTOR) inhibitor or clinical trial) including previously untreated patients
* Karnofsky Performance Status (KPS) of at least 70%
* Life expectancy of at least 3 months
* At least 2 metastatic sites of which at least 1 must be measurable as per RECIST 1.1
* Archival Formalin-fixed paraffin-embedded (FFPE) tumor tissue must be available for correlative studies (Note: Fine Needle Aspiration (FNA) and bone metastases samples are not acceptable for submission)
* Patients with favorable, intermediate and poor risk categories will be eligible for the study. Patients must be categorized according to favorable versus intermediate/poor risk status at registration. International Metastatic RCC Database Consortium (IMDC) must be used to determine prognostic factors
Exclusion Criteria:
* Subjects with previously treated brain or CNS (Central nervous system) metastases are eligible provided that the subject has recovered from any acute effects of radiotherapy and is not requiring steroids, and any whole brain radiation therapy was completed at least 4 weeks prior to study drug administration, or any stereotactic radiosurgery was completed at least 2 weeks prior to study drug administration. Liver metastases will not be included as part of the radiated lesions to be treated.
Medical History and Concurrent Diseases:
* Prior treatment with an anti-Programmed cell death(PD) -1, anti-PD-L1, anti-PD-L2, anti-CD137(cluster of differentiation), or anti-CTLA-4 (cytotoxic T-lymphocyte-associated protein ) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. Prior treatment with high dose interleukin (HD IL)-2 is allowed.
* Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (\> 10 mg daily prednisone equivalent) or immunosuppressive medications except for syndromes which would not be expected to recur in the absence of an external trigger. Subjects with vitiligo or type I diabetes mellitus or residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement are permitted to enroll. Patients with psoriasis not requiring active, systemic treatment are allowed.
* Any condition requiring systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug. Inhaled steroids and adrenal replacement steroid doses up to 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
* Uncontrolled adrenal insufficiency
* Requirement for anti-coagulation with Coumadin, low molecular weight heparin and anti-thrombin inhibitors will be accepted if anticoagulation has been stable for at least 4 weeks and no recent history of prior bleeding complications.
* Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix, breast or low risk Gleason 6 prostate cancer
* Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
* Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection
* Known medical condition (eg, a condition associated with diarrhea or acute diverticulitis) that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results
* Major surgery (eg, nephrectomy) less than 28 days prior to the first dose of study drug
* Anti-cancer therapy less than 14 days prior to the first dose of study drug or palliative, focal radiation therapy less than 14 days prior to the first dose of study drug
* Presence of any toxicities attributed to prior anti-cancer therapy, other than alopecia, that have not resolved to Grade 1 (NCI CTCAE v4) or baseline before administration of study drug
Physical and Laboratory Test Findings:
* Any of the following laboratory test findings:
* White blood cell (WBC) \< 2,000/mm3
* Neutrophils \< 1,500/mm3
* Platelets \< 100,000/mm3
* aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3 x ULN (\> 5 x ULN if liver metastases are present)
* Total Bilirubin \> 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL)
* Serum creatinine \> 1.5 x upper limit of normal (ULN) or creatinine clearance \< 40 mL/min (measured or calculated by Cockroft-Gault formula)
Allergies and Adverse Drug Reaction:
* History of severe hypersensitivity reaction to any monoclonal antibody or study drug components
Other Exclusion Criteria:
* Prisoners or subject who are involuntarily incarcerated
* Not suitable for SBRT treatment
* Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness <Conditions:>Kidney Cancer Metastatic, Kidney Cancer, Kidney Cancer, Stage IV <Interventions:>Nivolumab/Ipilimumab, SBRT | 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Breast Cancer Progressing After First-Line Therapy With Avastin and Chemotherapy (TANIA) <BriefSummary:>This randomized, open-label, parallel-group study will assess the efficacy and s afety of Avastin (bevacizumab) in combination with chemotherapy versus chemother apy alone as second- and third-line therapy in patients with locally recurrent o r metastatic breast cancer progressing after first-line therapy with Avastin and chemotherapy. Patients will be randomized to receive either Avastin (15 mg/kg e very 3 weeks or 10 mg/kg every 2 weeks intravenously) plus standard chemotherapy or chemotherapy alone. Anticipated time on study treatment is until third-line disease progression or unacceptable toxicity occurs. <EligibilityCriteria:>Inclusion Criteria:
* Female patients, \>/= 18 years of age
* Histologically confirmed HER2-negative breast cancer
* Disease progression during or following first-line treatment with Avastin and chemotherapy for locally recurrent or metastatic breast cancer
* Avastin treatment in first-line setting must have been a minimum of 4 cycles (15 mg/kg) or 6 cycles (10 mg/kg) in combination with chemotherapy
* ECOG performance status 0-2
* At least 28 days since prior radiation therapy or surgery and recovery from treatment
Exclusion Criteria:
* Anti-angiogenic therapy or anti-vascular endothelial growth factors other than Avastin for first-line treatment
* Active malignancy other than superficial basal cell and superficial squamous cell carcinoma of the skin, or in situ carcinoma of the cervix or breast within the last 5 years
* Inadequate renal function
* Clinically relevant cardio-vascular disease
* Known CNS disease except for treated brain metastases
* Chronic daily treatment with high-dose aspirin (\>325 mg/day) or clopidogrel (\>75 mg/day)
* Pregnant or lactating women <Conditions:>Breast Cancer <Interventions:>bevacizumab [Avastin], Chemotherapy | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Randomized Control Trial Comparing Prokinetics and Their Influence on Endoscopy Outcomes for Upper GI Bleed. <BriefSummary:>This is a study comparing the effect of erythromycin or metoclopramide, 2 prokinetic drugs (Drugs which are known to speed up the emptying of the stomach or in other words to move the blood out of the stomach faster) given before endoscopy to patients with upper Gastrointestinal bleeding compared to patients who will not receive either of these medications before their endoscopy. <EligibilityCriteria:>Inclusion Criteria:
* Adult patients (18-80)
* who are admitted to the ICU for hematemesis, or coffee ground emesis
Exclusion Criteria:
1. Patients younger than 18 yrs old or older than 80 yrs
2. Patients who refuse to consent to be in our study
3. Pregnant patients
4. Prior use of prokinetics in the last 48 hours
5. History of cardiac arrhythmia
6. Allergy to erythromycin or metoclopromide
7. Patients with QT prolongation (query 7)
- <Conditions:>Upper Gastrointestinal Bleeding <Interventions:>Erythromycin, Metoclopromide | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Metformin and Carbohydrate Restriction With Platinum Based Chemotherapy In Stage IIIB/IV Non-Squamous Non-Small Cell Lung Cancer (NS-NSCLC) <BriefSummary:>Metformin is thought to activate AMP-activated protein kinase (AMPK), a major sensor of cellular energy levels and a key enzyme limiting cellular growth during times of cellular stress. Once activated, this enzyme restricts anabolic processes such as protein, cholesterol and fatty acid synthesis and inhibits mTOR, a protein kinase responsible for unregulated growth. MTOR is upregulated in a variety of tumors, including NSCLC providing rationale to take advantage of this pathway with metformin. <EligibilityCriteria:>Inclusion Criteria:
1. Able to provide written consent and is amenable to compliance with protocol schedules and testing
2. Patient is \> 18 years of age
3. Pathologically proven (either histologic or cytologic) diagnosis of Stage IIIB or IV non-squamous non-small cell lung cancer
4. No prior, palliative chemotherapy for stage IV lung cancer Patients who have received adjuvant chemotherapy post surgery for curative intent more than 12 months prior to development of stage IV disease are allowed.
5. Measurable disease as RECIST criteria 1.1 (Response Evaluation Criteria in Solid Tumors, Version 1.1)
6. CT Scan of the chest/abdomen/pelvis or PET Scan within 30 days of study entry
7. An MRI of the brain or Head CT Scan with contrast within 30 days of study entry if clinically indicated
8. ECOG Performance Status 0-2.
9. CBC/differential obtained within 2 weeks prior to registration on study, with adequate bone marrow function defined as follows:
* Absolute neutrophil count (ANC) \>1,500 cells/ul
* Platelets \> 100,000 cells/ul
* Hemoglobin \> 9.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb \> g/dl is acceptable.)
10. Serum creatinine \< 1.5 x ULN
11. Total bilirubin \< 2.0 times the institutional Upper Limit of Normal (ULN)
12. AST and ALT \< 3.0 x the ULN
13. Women of childbearing potential must have:
* A negative serum or urine pregnancy test (sensitivity \<= 25IU HCG/L) within 14 days prior to the start of study drug administration
* Persons of reproductive potential must agree to use and utilize an adequate method of contraception throughout treatment and for at least 90 days after study drug is stopped prior to study enrollment, women of childbearing potential must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy.
14. Ability to take oral medication
Exclusion Criteria:
1. The patient has a diagnosis of squamous cell carcinoma. Adenosquamous (mixed) histologies are allowed
2. The patient has a history of type I or type II diabetes
3. Weight of less than 80% of (IBW) ideal body weight
4. Creatinine clearance less than 45 l/min as calculated by the Cockcroft-Gault equation
5. Known EGFR or ALK mutation in which targeted therapy with erlotinib or crizotinib would be the standard of care. Those patients whose tissue is not tested or have insufficient material are eligible
6. The patient is currently taking or has previously taken metformin in the past 6 months
7. The patient has received previous chemotherapy for NSCLC except in instances of adjuvant therapy post surgical resection more than 12 months prior to enrollment
8. The patient has undergone major surgery within four weeks prior to randomization.
9. The patient has undergone palliative radiation (chest, brain) to tumor sites within two weeks of randomization (except palliative radiation to the bone which can be within one week
10. Uncontrolled (untreated) brain metastasis.
11. Patient who has NCI-CTCAE Version 4 Grade \>= 2 diarrhea
12. That patient has clinically relevant CAD or uncontrolled CHF
13. The patient has ongoing or active infection (requiring antibiotics) that would limit the administration of chemotherapy including active TB. HIV is allowed in this study
14. The patient has a history of neurological or psychological disorder that may interfere with the compliance of the protocol
15. Women who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug, or have a positive pregnancy test at baseline, or are pregnant or breastfeeding <Conditions:>Non-small Cell Lung Cancer Stage IIIB/IV, Non-small Cell Lung Cancer Metastatic, Nonsquamous Nonsmall Cell Neoplasm of Lung <Interventions:>metformin, carbohydrate restricted diet | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>5-Year Follow-Up Safety and Performance Evaluation of the Medtentia Annuloplasty Ring in Adults <BriefSummary:>Single-center clinical investigation is to evaluate long-term safety and performance of the Medtentia Annuloplasty Ring (MAR) in 11 patients who underwent successful mitral valve (MV) surgery using Medtentia's MAR system in clinical investigation 2010-040 performed during June 2011 - April 2016. <EligibilityCriteria:>Inclusion Criteria:
* Signed Informed Consent Form.
* Subject had a successful MAR implantation in clinical investigation 2010-040.
* Subject is willing to participate in the follow-up study and to comply with the requirements of the Clinical Investigation Plan.
Exclusion Criteria:
* Subjects who participated in the clinical investigation 2010-040 but had the MAR replaced with another mitral valve repair ring or system. <Conditions:>Mitral Regurgitation, Mitral Insufficiency <Interventions:>Medtentia Annuloplasty Ring (MAR) | 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Tumor Gene Expression in Women With Ovarian Cancer <BriefSummary:>The study objective is to compare changes in expression of glucocorticoid-induced genes that may be involved in cell survival signaling in the tumors of ovarian cancer patients before and after an intraoperative dose of 20mg dexamethasone. <EligibilityCriteria:>Inclusion Criteria:
* Subject has intraabdominal disease either proven or strongly suspected to be ovarian or primary peritoneal cancer, and will be undergoing surgical debulking.
* Subject is not allergic to dexamethasone, and there is no obvious medical contraindication to dexamethasone.
* Subjects with diabetes requiring drug therapy are excluded.
* Subject is not currently receiving glucocorticoid therapy
* Nasal steroids (e.g. Flonase) are permitted
* Subject understands that this protocol does not have therapeutic intent
* Preoperative serum albumin at least 3.0 mg/dL
* Negative serum or urine pregnancy test in women of childbearing potential
* Signed informed consent
Exclusion Criteria:
* Males do not get ovarian cancer and therefore will not be included in this trial.
* Patients of all ethnic backgrounds are eligible and will be encouraged to enroll. However we do not expect differences based on ethnicity, and this small study will not therefore be powered to make conclusions about ethnic differences in induction of GR-regulated genes with dexamethasone. <Conditions:>Ovarian Cancer <Interventions:>Dexamethasone, Placebo | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study of Pegylated Interferon Alfa-2A in Combination With Lamivudine or Entecavir Compared With Untreated Control Group in Children With Hepatitis B Envelope Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB) in the Immune-Tolerant Phase <BriefSummary:>This randomized, controlled, parallel group, open-label multicenter study will evaluate the efficacy and safety of a combination of pegylated interferon alfa-2A (Pegasys) plus lamivudine or entecavir compared with an untreated control group in participants with HBeAg positive CHB in the immune tolerant phase. NOTE: STUDY RECRUITMENT HAS BEEN TERMINATED <EligibilityCriteria:>Inclusion Criteria:
* Positive for HBsAg and HBeAg for more than 6 months prior to baseline
* Detectable HBV-DNA (\>20,000 IU/mL) as measured by polymerization chain reaction (PCR) or hybridization on at least 2 occasions at least one month apart with the latest determination obtained less than or equal to (\</=) 42 days prior to baseline
* Compensated liver disease (Child-Pugh Class A clinical classification)
* Either Liver biopsy performed within 2 years prior to baseline showing no or minimal fibrosis (Liver Biopsy Scores and stable normal ALT levels (less than or equal to upper limit of normal \[ULN\]) during the 6 months leading up to baseline (including two separate occasions at least 1 month apart over the 6 months prior to baseline). Screening ALT levels must be normal (\</= ULN) OR Stable normal ALT levels (\</= ULN), during the 1 year leading up to baseline (including three separate occasions at least 1 month apart over the 1 year prior to baseline) and no signs of hepatocellular carcinoma (HCC), advanced fibrosis/cirrhosis, or splenomegaly on liver abdominal ultrasound at screening. Screening ALT levels must be normal (\</= ULN)
Exclusion Criteria:
* Participants who have received investigational drugs or licensed treatments with anti HBV activity (Exception: Participants who have had a limited \[\</= 7-day\] course of acyclovir for herpetic lesions more than 1 month before the study baseline visit are not excluded)
* Participants who have participated in any other clinical trial or who have received any investigational drug within 6 months prior to baseline
* Known hypersensitivity to interferon (IFN), pegylated interferon-alfa-2a or lamivudine or entecavir
* Positive test results at screening for hepatitis A virus Immunoglobulin M (IgM) antibody (Ab), anti-hepatitis C virus (HCV) Ab, anti- hepatitis D (HDV) Ab or anti-human immunodeficiency virus (HIV) Ab
* Decompensated liver disease (e.g., Child-Pugh Class B or C clinical classification or clinical evidence such as ascites or varices)
* Advanced fibrosis or cirrhosis
* Suspicion of HCC on liver abdominal ultrasound (all patients to have liver abdominal ultrasound within 6 months prior to baseline)
* History or other evidence of a medical condition associated with chronic liver disease other than CHB including metabolic liver diseases such as hemochromatosis, Wilson's disease or alpha-1 anti-trypsin deficiency
* Active substance abuse within 6 months prior to screening
* Sexually active females of childbearing potential and sexually active males who are not willing to utilize reliable contraception during treatment and for 90 days following the end of treatment
* Females who are pregnant or who are breastfeeding (females of childbearing potential who have a positive urine or serum pregnancy test result within 24 hours of baseline are excluded) <Conditions:>Pediatric Immuno-Tolerant Chronic Hepatitis B <Interventions:>Entecavir, Lamivudine, Pegylated Interferon Alfa-2A | 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Race/Ethnicity, Customized' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>BMS-Reyataz Study in Treatment in Naive Subjects to Compare the Efficacy and Safety Between Boosted Reyataz and Kaletra When in Combination With Fixed Dose Truvada <BriefSummary:>The purpose of this study is to evaluate the safety, tolerability and antiviral effects of atazanavir (ATV) plus ritonavir (RTV) versus a combination drug of lopinavir (LPV) plus RTV. A combination drug containing tenofovir (TDF) and emtricitabine (FTC) will also be taken by participants in both arms. <EligibilityCriteria:>Inclusion Criteria:
* HIV RNA ≥5000 c/ml
Exclusion Criteria:
* Any antiretroviral therapy within 30 days prior to screening;
* Women of Childbearing potential (WOCBP) unwilling or unable to use an acceptable method to avoid pregnancy for the entire study and for up to 8 weeks after the study;
* WOCBP using a prohibited contraceptive method
* WOCBP who are pregnant or breastfeeding;
* Women with a positive pregnancy test on enrollment or prior to study drug administration;
* Presence of a newly diagnosed HIV-Related opportunistic infection or any medical condition requiring acute therapy at the time of enrollment;
* Suspected primary (acute) HIV infection;
* Prior antiviral therapy (\>30 days of NRTI and/or \>7 days of non-nucleoside reverse transcriptase inhibitor (NNRTI) or PI therapies) or any antiretroviral therapy within 30 days prior to screening; some exceptions are allowed for ARV therapy in use for Mother-to-child transmission;
* Participants with Cushing's syndrome;
* Untreated hypothyroidism or hyperthyroidism. A participant who is euthyroid on a stable replacement dose of thyroid hormone is acceptable provided the thyroid stimulating hormone (TSH) performed within 30 days of screening is within normal drug range;
* Recent therapy with agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic or cytotoxic potential within 3 months of study start or expected need for such therapy at the time of enrollment; or therapy with methadone or ribavirin/interferons or treatment with neurotoxic drugs or drugs that affect CYP3A4;
* Participants with obstructive liver disease;
* Active alcohol or substance use sufficient, in the Investigator's opinion, to prevent adequate compliance with study therapy or to increase the risk of developing pancreatitis or chemical hepatitis;
* Proven or suspected acute hepatitis in the 30 days prior to study entry;
* Intractable diarrhea (≥6 loose stools/day for at least 7 consecutive days) within 30 days prior to study entry;
* Inability to swallow capsules;
* Active peripheral neuropathy;
* Presence of cardiomyopathy (due to any cause) or any significant cardiovascular disease, such as unstable ischemic heart disease;
* Known, clinically significant cardiac conduction system disease.
* Baseline laboratory values measured within 2 weeks prior to initiating study drugs as follows:
1. calculated creatine clearance \<60 mL/min as estimated by the Cockcroft-Gault equation;
2. total serum lipase ≥ 1.4 times the upper limit of normal;
3. liver enzymes (AST, ALT) ≥ 5 times the upper limit of normal;
4. total serum bilirubin ≥ 1.5 times the upper limit of normal.
* Hypersensitivity to any component of the formulation of study drug;
* Prohibited therapies;
* Any other clinical conditions or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for study or unable to comply with the dosing requirements;
* Prisoners or participants who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study. <Conditions:>HIV Infections <Interventions:>ATV, RTV, Tenofovi-Emtricitabine (TDF/FTC) tablet, LPV | 'Age Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Oral Versus Topical Antibiotics for Chronic Rhinosinusitis Exacerbations <BriefSummary:>The purpose of this study is to treat patients with a diagnosis of chronic rhinosinusitis (CRS) and a history of bilateral endoscopic sinus surgery during times of worsening symptoms and signs of acute infection on nasal endoscopy with one of two treatments: (1) oral antibiotics and twice daily intranasal saline irrigations or (2) oral placebo and twice daily intranasal antibiotic irrigations. The two treatments will be compared to see if there is any difference in patient outcomes. This will help guide treatment strategies for patients with CRS in the future. <EligibilityCriteria:>Inclusion Criteria:
1. Adults (age ≥ 18).
2. Diagnosis of CRS.
3. Worsening sinonasal symptoms.
4. Previous bilateral endoscopic sinus surgery (ESS) (including maxillary antrostomy and anterior ethmoidectomy).
5. English speaking.
6. Open sinuses (open middle meatus bilaterally; determined on endoscopy).
7. Positive sinonasal culture (1+ or greater) with sensitivity to one of the pre-chosen antibiotic regimens.
Exclusion Criteria:
1. Patients \< 18 years of age.
2. Treatment with systemic or topical antibiotics within the last 1 month.
3. Pregnant women.
4. Non-English speaking persons.
5. Systemically ill at initial visit necessitating treatment prior to culture data.
6. Allergies to chosen susceptible antibiotics.
7. Sinonasal culture with less than 1+ growth.
8. Multiple organisms grown on culture that are not sensitive to a single antibiotic.
9. Patients with ciliary function disorders (cystic fibrosis, Kartagener's syndrome, ciliary dyskinesia).
10. Patients with immunodeficiencies. <Conditions:>Chronic Rhinosinusitis <Interventions:>oral levofloxacin, nebulized levofloxacin | 'Age, Categorical', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Tooth Sensitivity Relief by Two Mouthrinses <BriefSummary:>This study is for people with sensitive teeth and involves going to the dentist for 6 visits over 8 weeks. During the first 2 weeks, everyone will just brush their teeth two times a day with the fluoride toothpaste provided.
Then you will be assigned to a mouthwash group if you qualify to continue in the study. Two groups will get mouthwash with a certain amount of an experimental ingredient and one group will get a mouthwash with no experimental ingredients. You will have an equal chance of being assigned to any one of the three groups.
For the next 6 weeks, you will rinse with your assigned mouthwash after brushing. A dentist will look at your mouth, teeth, tongue and gums and check for sensitive teeth. The investigators will see if the mouthwash helps to reduce tooth sensitivity during the study. <EligibilityCriteria:>Inclusion Criteria:
* Males and females at least 18 years of age in good general and oral health without any known allergy to commercial dental products or cosmetics.
* Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial
* Willingness to use the assigned products according to instructions, availability for appointments, and likelihood of completing the clinical trial.
* A minimum of 2 natural premolars, canines, and/or incisors teeth with decay-free scorable facial/buccal surfaces which must present cervical abrasion, and/or erosion and/or gingival recession.
* A minimum of two eligible teeth (premolars, canines and/or incisors) with a Screening (-2 weeks Baseline) and Baseline tactile sensitivity score between 10 - 50 grams after application of the Yeaple probe and a cold air stimulus VAS score of 30 - 80 mm on a 100 mm VAS scale will be followed as study teeth during the trial.
* No more than two eligible teeth per quadrant each separated by 2 other teeth must be selected.Absence of significant oral soft tissue pathology, based on the dentist's visual examination and at the discretion of the investigator.
* Adequate oral hygiene (i.e. brush teeth daily and exhibit no signs of oral neglect).
* Absence of severe marginal gingivitis, moderate/advanced periodontitis (ADA Type III, IV) based on a clinical examination and discretion of the Investigator.
* Absence of extensive supragingival calculus.
Exclusion Criteria:
* Volunteers who report history or presence of kidney disorders, kidney stones, eating disorders, uncontrolled GERD, excessive dietary or environmental exposure to acids, or other systemic conditions that are predisposing to dentinal hypersensitivity.
* Volunteers with chronic medical debilitating disease associated with constant or intermittent episodes of daily pain.
* Long-term daily use (≥ 7 consecutive days) of analgesics and any other drugs that at the discretion of the Investigator would compromise the response of the hypersensitivity assessments.
* Volunteers who have been using any home-care bleaching, whitening products or have had a professional bleaching treatment within 4 weeks of the Screening visit.
* Use of desensitizing agents whether prescribed or over-the-counter within eight weeks prior to screening visit (any sensitivity toothpastes such as Crest Sensitivity, Sensodyne, Crest Pro-Health, Colgate Sensitivity Relief, any mouthwash and oral care products used for the treatment of dentinal hypersensitivity).
* Volunteers who during the study will receive dental treatment which may affect their dentinal hypersensitivity condition (i.e. oral prophylaxis). Emergency treatment will be allowed.
* Those requiring antibiotic premedication prior to invasive dental procedures.
* Participation in a dental clinical trial involving oral care products within the past 30 days.
* Women who are pregnant, nursing or plan to become pregnant during the course of the study.
* Teeth that are grossly carious, orthodontically banded, abutment teeth for fixed or removable prostheses, crowned teeth, or third molars will not be included in the study.
* Periodontal surgery and orthodontic treatment within previous 3 months.
* Extensive restorative treatment (i.e. extensively restored teeth or teeth with restoration(s) extending into the test area) at the discretion of the Investigator.
* Dental prophylaxis within 2 weeks prior to Screening visit.
* Teeth or periodontium with pathology or defect likely to cause pain.
* Teeth with clinical mobility \> grade 1. <Conditions:>Dentin Sensitivity <Interventions:>12027-019, 12027-020, 12027-021 | 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>The Effect of White Sweet Potato Meal Replacement on Weight Control of the Obesity <BriefSummary:>The purpose of this project is to use white-skinned sweet potato as the main material for weight control for overweight and obesity, the non-communicable diseases (cardiovascular diseases, cancers, chronic respiratory diseases and diabetes) are also included. All high quality sweet potato are provided by CAES in Taiwan to produce special nutrient food and health food that to do functional study in Shih Chien University and Taipei Medical University. In this study, the investigators will recruit overweight and obesity subjects that divide into white sweet potato group (experimental group) and no intervention group (control group) by using randomized, parallel and open clinical study in sixty days. <EligibilityCriteria:>Inclusion Criteria:
* 24≦ BMI≦30
Exclusion Criteria:
* Pregnant and lactating women
* Patients within six months after surgery
* Mental illness or depression
* Suffering from cancer, ulcers, acute respiratory infections, dialysis, acute hepatitis and other diseases
* Those who have taken "additional nutritional supplements" habit <Conditions:>Overweight <Interventions:>White sweet potato diet | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Study of Gelesis100 on Body Weight in Overweight and Obese Subjects With and Without Type 2 Diabetes <BriefSummary:>This study will asses the decrease in body weight after repeated administration of Gelesis100 in overweight and obese subjects with and without Type 2 Diabetes. <EligibilityCriteria:>Inclusion Criteria:
* Age 22 to 65 years of age, inclusive
* Signed Informed Consent Form
* BMI 27 to 40, inclusive (BMI of \<30 should have at least one comorbidity)
* Fasting plasma glucose 90mg/dL to 145 mg/dL, inclusive; non-diabetic normoglycemic (fasting glucose 90 mg/dL to 100 mg/dL, inclusive); non-diabetic impaired fasting glucose 100mg/dL to 126 mg/dL; and diabetic: untreated (126 mg/dL to 145 mg/dL, inclusive) and metformin-treated (metformin dose 1500mg/DL and less, fasting glucose less than 145 mg/dL, inclusive)
Exclusion Criteria:
* Pregnancy or lactation
* Absence of medically approved contraceptive methods in females of childbearing potential
* History of allergic reaction to modified cellulose, citric acid, sodium stearyl fumarate, raw cane sugar, gelatin, and titanium oxide
* Administration of investigational products within 1 month prior to Screening Visit
* Subjects who stopped smoking within 6 months prior to Screening Visit or considering smoking cessation during the study
* Subjects anticipating surgical intervention during the study
* Known Type 1 diabetes
* History of eating disorders
* Angina, coronary bypass, or myocardial infarction within 6 months prior to Screening Visit
* History of: swallowing disorders, esophogeal anatomic abnormalities, gastroesophageal reflux disease, gastric or duodenal ulcer, gastroparesis (chronic nausea, vomiting, heartburn...), gastric bypass or other gastric surgery, intestinal obstruction or at high risk of including suspected small bowel adhesion, pancreatitis, malabsorption, history of bowel resection (except if related to appendectomy), history of abdominal radiation treatment
* Laxative users
* History of: HIV, hepatitis B or C; cancer within the past 5 years
* Abnormal serum thyroid-stimulating hormone (TSH)
* Positive urine drug test
* Anti-obesity medication within 1 month prior to Screening Visit (except stable doses of metformin, no more than 1500 mg/day, for at leaset 1 month in subjects with type 2 diabetes)
* Systemic corticosteroids within 1 month prior to Screening Visit
* Thyroid hormones or preparations within 1 month prior to Screening Visit
* Estrogen within 1 month prior to Screening Visit
* Any other medication known to cause weight loss or weight gain within 1 month prior to Screening Visit
* TSH suppression therapy for thyroid cancer
* medications requiring mandatory administration with meal (lunch or dinner), except metformin
* Other medication or product used for chronic diseases if their impaired gastrointestinal absorption can cause safety issues
* Change in medications treating hypertension and/or dyslipidemia within 1 month prior to Screening Visit (including change in dose)
* Anticipated requirement for use of prohibited concomitant medication <Conditions:>Overweight, Obesity <Interventions:>Gelesis100, placebo | 'Age, Categorical', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race/Ethnicity, Customized', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Stem Cell Transplantation in Patients With High-Risk and Recurrent Pediatric Sarcomas <BriefSummary:>This study will examine the safety and effectiveness of stem cell transplantation for treating patients with sarcomas (tumors of the bone, nerves, or soft tissue). Stem cells are immature cells in the bone marrow and blood stream that develop into blood cells. Stem cells transplanted from a healthy donor travel to the patient's bone marrow and begin producing normal cells. In patients with certain cancers, such as leukemia and lymphoma, the donor's immune cells attack the patient's cancer cells in what is called a "graft-versus-tumor" effect, contributing to cure of the disease. This study will determine whether this treatment can be used successfully to treat patients with sarcomas.
Patients between 4 and 35 years of age with a sarcoma that has spread from the primary site or cannot be removed surgically, and for whom effective treatment is not available, may be eligible for this study. Candidates must have been diagnosed by the age of 30 at the time of enrollment. They must have a matched donor (usually a sibling). Participants undergo the following procedures:
Donors: Stem cells are collected from the donor. To do this, the hormone granulocyte colony stimulating factor (G-CSF) is injected under the skin for several days to move stem cells out of the bone marrow into the bloodstream. Then, the cells are collected by apheresis. In this procedure the blood is drawn through a needle placed in one arm and pumped into a machine where the stem cells are separated out and removed. The rest of the blood is returned to the donor through a needle in the other arm.
Patients: For patients who do not already have a central venous catheter (plastic tube), one is placed into a major vein. This tube can stay in the body the entire treatment period for giving medications, transfusing blood, , withdrawing blood samples, and delivering the donated stem cells. Before the transplant procedure, patients receive from one to three cycles of "induction" chemotherapy, with each cycle consisting of 5 days of fludarabine, cyclophosphamide, etoposide, doxorubicin, vincristine, and prednisone followed by at least a 17-day rest period. All the drugs are infused through the catheter except prednisone, which is taken by mouth. After the induction therapy, the patient is admitted to the hospital for 5 days of chemotherapy with high doses of cyclophosphamide, melphalan, and fludarabine. Two days later, the stem cells are infused. The anticipated hospital stay is about 3 weeks, but may be longer if complications arise. Patients are discharged when their white cell count is near normal, they have no fever or infection, they can take sufficient food and fluids by mouth, and they have no signs of serious graft-versus-host disease (GVHD)-a condition in which the donor's cells "see" the patient's cells as foreign and mount an immune response against them.
After hospital discharge, patients are followed in the clinic at least once or twice weekly for a medical history, physical exam, and blood tests for 100 days. They receive medications to prevent infection and GVHD and, if needed, blood transfusions. If GVHD has not developed by about 120 days post transplant, patients receive additional white cells to boost the immune response. After 100 days, follow-up visits may be less frequent. Follow-up continues for at least 5 years. During the course of the study, patients undergo repeated medical evaluations, including blood tests and radiology studies, to check on the cancer and on any treatment side effects. On four occasions, white blood cells may be collected through apheresis to see if immune responses can be generated against the sarcomas treated in this study. Positron emission tomography (PET) scans may be done on five occasions. This test uses a radioactive material to produce images useful in detecting primary tumors and cancer that has spread. <EligibilityCriteria:>* INCLUSION CRITERIA: PATIENT
The following diagnoses will be considered:
1. Patients with Ewing's sarcoma family of tumors, or alveolar
rhabdomyosarcoma in one of the following categories:
* Patients who present at the time of initial diagnosis with bone or bone marrow metastases may be enrolled after completion of standard front-line therapy. Standard front line therapy for alveolar rhabdomyosarcoma should include vincristine and cyclophosphamide, plus actinomycin D and/or adriamycin. For patients with Ewing's sarcoma, standard front line therapy should include vincristine, cyclophosphamide, adriamycin, ifosfamide and etoposide.
* Patients with recurrence of tumor at any site less than one year after completing standard front-line therapy or with a second or subsequent recurrence at any time after completing standard front-line therapy.
* Patients with progression or persistence of disease while receiving standard front-line chemotherapy who cannot achieve a complete response (CR) with local treatment modalities.
2. The following patients with desmoplastic small round cell tumor are eligible after receiving front line standard therapy, which is defined as a regimen containing at least vincristine, cyclophosphamide, and adriamycin:
* unresectable disease
* metastatic tumor (abdominal and extra-abdominal disease)
* progressive or persistent while receiving standard therapy
* recurrence within one year of completing therapy
* Patients without evaluable tumor at the time of enrollment are eligible
* Patients who have previously received high-dose chemotherapy with autologous stem cell rescue are eligible for this trial.
* Patient age 5-35 at enrollment.
* Availability of a 5 or 6 antigen human leukocyte antigen (HLA)-matched first-degree relative donor (single HLA-A or B mismatch allowed). Genotypically identical twins may serve as stem cell donors. Genotypic identity must be confirmed by restrictive fragment length polymorphism (RFLP) analysis.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 or, for children less than or equal 10 years of age, Lansky greater than or equal 60
* Cardiac function: Left ventricular ejection fraction greater than or equal to 45% by multi-gated acquisition scan (MUGA), fractional shortening greater than or equal 28% by echocardiogram (ECHO) or left ventricular ejection fraction greater than or equal 55% by ECHO.
* Pulmonary function: carbon monoxide diffusing capacity (DLCO) greater than or equal to 50% of the expected value corrected for alveolar volume.
* Renal function: Age-adjusted normal serum creatinine according to the following table or a creatinine clearance greater than or equal to 60 ml/min/1.73 m\^2. Age (years) Maximum serum creatinine (mg/dl) less than or equal to 5 0.8 greater than 5, less than or equal to 10 1.0 greater than 10, less than or equal to15 1.2, greater than 15 1.5
* Liver function: Serum total bilirubin less than 2 mg/dl, serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 2.5 times upper limit of normal.
* Marrow function: absolute neutrophil count (ANC) must be greater than 750/mm\^3 (unless due to underlying disease in which case there is no grade restriction), platelet count must be greater than or equal to 75,000/mm\^3 (not achieved by transfusion) unless due to underlying disease in which case there is no grade restriction). Lymphopenia, cluster of differentiation 4 (CD4) lymphopenia, leukopenia, and anemia will not render patients ineligible.
* Ability to give informed consent. For patients less than18 years of age their legal guardian must give informed consent. Pediatric patients will be included in age appropriate discussion in order to obtain verbal assent.
* Durable power of attorney form completed (patients greater than or equal to18 years of age only).
INCLUSION CRITERIA: DONOR
* Weight greater than or equal 15 kilograms.
* First degree relative with genotypic identity at 5 or 6 HLA loci (single HLAA or B locus mismatch allowed). Genotypically identical twins may serve as stem cell donors. Genotypic identity must be confirmed by RFLP analysis.
* For donors less than 18 years of age, he/she must be the oldest suitable donor, their legal guardian must give informed consent, the donor must give verbal assent, and he/she must be cleared by social work and a mental health specialist to participate.
* For donors greater than or equal to 18 years of age, ability to give informed consent.
* Adequate peripheral venous access for apheresis or consent to use a temporary central venous catheter for apheresis.
* Donor selection criteria will be in accordance with National Institutes of Health (NIH)/Clinical Center (CC) Department of Transfusion Medicine Standards.
EXCLUSION CRITERIA: PATIENT
* Uncontrolled fungal infection.
* History of untreated CNS tumor involvement. Extradural masses which have not invaded the brain parenchyma (as is commonly observed in Ewing's sarcoma family of tumors) or parameningeal tumors (as is commonly observed in rhabdomyosarcoma) without evidence for leptomeningeal spread will not render the patient ineligible. Patients with previous central nervous system (CNS) tumor involvement that has been treated and has been stable for at least 6 weeks are eligible.
* Lactating or pregnant females.
* Human immunodeficiency virus (HIV) positive (due to unacceptable risk following allogeneic transplantation).
* Hepatitis B surface antigen (HBsAg) positive or hepatitis C antibody positive with elevated liver transaminases. All patients with chronic active hepatitis (including those on treatment) are ineligible.
* High risk of inability to comply with transplant protocol, or inability to give appropriate informed consent in the estimation of the principal investigator (PI), social work, or the stem cell transplant team.
* Fanconi Anemia
EXCLUSION CRITERIA: DONOR
* History of medical illness which poses a risk to donation in the estimation of the PI or the Department of Transfusion Medicine physician including, but not limited to stroke, hypertension that is not controlled with medication, or heart disease. Individuals with symptomatic angina or a history of coronary bypass grafting or angioplasty will not be eligible.
* History of congenital hematologic, immunologic, oncologic or metabolic disorder, which poses a prohibitive risk to the recipient in the estimation of the PI.
* Anemia (Hb less than 11 gm/dl) or thrombocytopenia (platelets less than 100,000/micro l).
* Lactating or pregnant females. Donors of childbearing potential must use an effective method of contraception during the time they are receiving growth colony stimulating factor (G-CSF). The effects of cytokine administration on a fetus are unknown and may be potentially harmful. The effects upon breast milk are also unknown and may potentially be harmful to the infant.
* Human immunodeficiency virus (HIV)-positive, hepatitis B surface antigen (HBsAg) positive or hepatitis C antibody positive. Donors are providing an allogeneic blood product and there is the potential risk of transmitting these viral illnesses to the recipient.
* High risk of inability to comply with transplant protocol. <Conditions:>Sarcoma <Interventions:>F-18 Fluorodeoxyglucose, therapeutic allogeneic lymphocytes, cyclophosphamide, cyclosporine, doxorubicin hydrochloride, etoposide, fludarabine phosphate, melphalan, prednisone, sirolimus, tacrolimus, vincristine sulfate, peripheral blood stem cell transplantation, Filgrastim, Peripheral Blood Stem Cell donation | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment', 'Number of Prior Regimens of Participants that Received Stem Cell Transplant', 'Number of Prior Regimens of Participants that Did Not Receive Stem Cell Transplant', 'Participants who Received Stem Cell Transplant Disease Status at Enrollment', 'Participants who Did Not Receive Stem Cell Transplant Disease Status(Progressive Disease)/Enrollment', 'Disease Status at Hematopoietic Stem Cell Transplant', 'Disease Status (Progressive Disease) at Hematopoietic Stem Cell Transplant', 'Diagnosis (Participants that Received Stem Cell Transplant)', 'Diagnosis (Participants that Did Not Receive Stem Cell Transplant)', 'High-Risk Features (Participants that Received Stem Cell Transplant)', 'High-Risk Features (Participants that Did Not Receive Stem Cell Transplant)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Phase II Study of Pembrolizumab and Lenvatinib in Advanced Well-differentiated Neuroendocrine Tumors <BriefSummary:>The purpose of this study is to:
* Assess overall radiographic response rate (ORR)
* Assess progression-free survival (PFS)
* Test the safety and tolerability of Pembrolizumab in combination with lenvatinib <EligibilityCriteria:>Inclusion Criteria:
* Diagnosis/Condition for entry into the trial: Metastatic well differentiated neuroendocrine tumors of primary lung, thymic, small bowel and colorectal origin (including unknown primary)
* Evidence of radiographic disease progression with scan documenting progression occurring within 8 months of signing informed consent
* At least two prior lines of systemic treatment. If the only prior line of treatment was adjuvant or neoadjuvant, patient must have completed treatment within 12 months. There is no limit to number of prior therapies.
* Willing and able to provide written informed consent/assent for the trial.
* ≥ 18 years of age on day of signing informed consent.
* Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
* Demonstrate adequate organ function and laboratory values. All screening labs should be performed within 14 days of treatment initiation.
* Females of childbearing potential (FOCBP) should have a negative serum pregnancy within 72 hours prior to receiving the first dose of study medication.
* FOCBP must agree to use adequate contraception as outlined in study documentation for the course of the through 120 days after the last dose of study medication.
* Male participants of childbearing potential must agree to use an adequate method of contraception as outlined in study documentation, starting with the first dose of study therapy through 120 days after the last dose of study therapy.
Exclusion Criteria:
* Poorly differentiated neuroendocrine carcinoma
* Pancreatic neuroendocrine tumor
* Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
* A diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
* Known history of active TB (Bacillus Tuberculosis)
* Hypersensitivity to pembrolizumab or any of its excipients.
* Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
* Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. - Note: Potential participants with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study. Note: If have received major surgery within 3 weeks, must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy. Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility.
* Serious non-healing wound, ulcer or bone fracture
* Has pre-existing \>/= Grade 3 gastrointestinal (GI) or non-GI fistula
* Has significant cardiovascular impairment within 12 months of the first dose of study drug
* Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Potential participants with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
* Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic treatment.
* History of (non-infectious) pneumonitis that required steroids, or current pneumonitis.
* An active infection requiring systemic therapy.
* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
* Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
* Has received prior therapy with a tyrosine kinase inhibitor (TKI) (e.g.; sunitinib, pazopanib, cabozantinib)
* Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
* Known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA \[qualitative\] is detected).
* Has received a live vaccine within 30 days of planned start of study therapy. Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.
* Uncontrolled hypertension defined as systolic blood pressure \>150 mmHg or diastolic pressure \>90 mmHg, despite optimal medical management
* Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic, attacks, DVT within the past 6 months
* Bleeding or thrombotic disorders or use of anticoagulants, such as warfarin, or similar agents requiring therapeutic international normalized ration (INR) monitoring.(Treatment with low molecular weight heparin (LMWH) is allowed)
* Marked baseline prolongation of QT/QTc interval (QTc interval ≥ 480 msec) using the Fridericia method (QTc = QT/RR0.33) for QTc analysis
* Clinically significant bleeding within 4 weeks
* Medical need for the continued use of potent inhibitors/inducers of CYP3A4
* Creatinine clearance \<30 mL/min
* Any condition that impairs patient's ability to swallow whole pills or gastrointestinal malabsorption that, in the investigator's opinion, might affect absorption of lenvatinib <Conditions:>Neuroendocrine Tumors, Neuroendocrine Carcinoma, Neuroendocrine Cancer <Interventions:>Pembrolizumab, Lenvatinib | 'Age, Categorical', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Gown and Glove Use to Prevent the Spread of Infection in VA Community Living Centers <BriefSummary:>Methicillin-resistant S. aureus (MRSA) infections are a common cause of morbidity and mortality in nursing home residents. MRSA is predominantly spread from patient-to-patient by health care workers. The use of gowns, gloves and hand washing prevents this spread; however, their use detracts from a patient-centered, home-like environment which is an important priority for nursing homes. The goal of this project is to determine when it is most important for health care workers to wear gowns and to wash their hands when caring for MRSA colonized Veterans in community living centers. <EligibilityCriteria:>Inclusion Criteria:
Resident:
* Age 18 years
* Reside in a participating LTCF for rehabilitation, skilled nursing or maintenance care
* Expected length of stay of \>4 weeks from enrollment
* Written informed consent from participant, or written informed consent from legally authorized representative (LAR) with assent from participant
Health Care Worker:
* Has direct interaction with participating residents at participating VA Long Term Care Facility (LTCF)
* Verbal informed consent
Exclusion Criteria:
Residents:
* None
Health Care Worker:
* Unable or unwilling to wear protective gown or gloves during healthcare workers (HCW)-resident interaction <Conditions:>Methicillin-Resistant Staphylococcus Aureus <Interventions:>No Interventions | 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>High Definition Endoscopy With i-Scan for Small Colonic Polyp Evaluation: The HiScope Study <BriefSummary:>Current standard practice is to remove all colonic polyps found during colonoscopy as it has not been possible to distinguish between polyps with some malignant potential (adenomatous) and those with negligable malignant potential (non-adenomatous).
Recent advances in endoscope imaging and technology have allowed endoscopists to distinguish between these two types of polyps by examining minute surface details.
i-Scan is a new digital enhancement method that aims to enhance surface details and may enable similar accurate distinction between adenomatous and non-adenomatous polyps.
Hypothesis:
High definition white light endoscopy plus i-Scan improves diagnostic accuracy of in-vivo assessment of colonic polyps \<10mm in size over high definition white light endoscopy alone. <EligibilityCriteria:>Inclusion Criteria:
* Patients found to have colonic polyps up to 10mm in size
Exclusion Criteria:
* Poor bowel preparation
* Inflammatory bowel disease
* Polyposis syndrome <Conditions:>Colonic Polyps <Interventions:>High definition white light endoscopy | 'Age Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Virtual Reality Mobility Training System for Veterans With Vision Loss <BriefSummary:>This is a two-year proof-of-concept study to evaluate a new Virtual Reality (VR) "holographic" sound system for use as an audiological Orientation and Mobility (O\&M) training tool <EligibilityCriteria:>Inclusion Criteria:
* Must have little or no light perception
* OMCT (Orientation-Memory Concentration Test) of 10 or less
* Must have been independently and regularly crossing busy intersections for at least 3 years
* Ambulatory and able to walk for at least 10 minutes at a time without resting
* Auditory function at 25 db HL
Exclusion Criteria:
* Imbalance between ears - HL difference of 20 db HL or more <Conditions:>Blindness <Interventions:>Virtual Sound System | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study of Tarceva (Erlotinib) or Placebo in Combination With Platinum-Based Therapy as First Line Treatment in Patients With Advanced or Recurrent Non-Small Cell Lung Cancer <BriefSummary:>This 2 arm study will compare the efficacy and safety of sequential treatment with Tarceva or placebo, plus platinum-based therapy, as first line treatment in patients with advanced or recurrent non-small cell lung cancer. Patients will be randomized to receive gemcitabine (1250mg/m2 iv) on days 1 and 8, and cisplatin (75mg/m2) or carboplatin (5xAUC)on day 1, followed by Tarceva 150mg/day or placebo from day 15 to day 28 of each 4 week cycle for a total of 6 cycles,then followed by Tarceva or placebo monotherapy.The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. <EligibilityCriteria:>Inclusion Criteria:
* adult patients, \>=18 years of age;
* advanced (stage IIIB/IV)non-small cell lung cancer;
* measurable disease;
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
Exclusion Criteria:
* prior exposure to agents directed at the HER axis;
* prior chemotherapy or systemic anti-tumor therapy after advanced disease;
* unstable systemic disease;
* any other malignancy within last 5 years, except cured basal cell cancer of skin or cured cancer in situ of cervix;
* brain metastasis or spinal cord compression. <Conditions:>Non-Squamous Non-Small Cell Lung Cancer <Interventions:>Placebo, Platinum chemotherapy (cisplatin or carboplatin), erlotinib [Tarceva], gemcitabine | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>The Pediatric Artificial Pancreas (PEDAP) Trial of Control-IQ Technology in Young Children in Type 1 Diabetes <BriefSummary:>The purpose of this study is to learn whether an investigational automated insulin delivery system ("study system") for young children (2 yo to less than 6 yo) with type 1 diabetes can safely improve blood glucose (sometimes called blood sugar) control. <EligibilityCriteria:>Inclusion Criteria:
1. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 6 months and using insulin for at least 6 months
2. Familiarity and use of a carbohydrate ratio for meal boluses.
3. Age ≥2 and \<6 years old
4. Living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff.
5. Investigator has confidence that the parent can successfully operate all study devices and is capable of adhering to the protocol
6. Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study for participants using a study-provided Tandem pump during the study.
• Study will not be providing insulin; therefore, participants will need to have access to either lispro or aspart
7. Total daily insulin dose (TDD) at least 5 U/day
8. Body weight at least 20 lbs.
9. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (see section 2.3)
10. Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff.
11. Parent/guardian proficient in reading and writing English.
Exclusion Criteria:
1. Concurrent use of any non-insulin glucose-lowering agent (including Glucagon-like peptide-1 \[GLP-1\] agonists, Symlin, Dipeptidyl peptidase-4 \[DPP-4\] inhibitors, Sodium-glucose Cotransporter-2 (SGLT-2) inhibitors, sulfonylureas).
2. Hemophilia or any other bleeding disorder
3. History of \>1 severe hypoglycemic event with seizure or loss of consciousness in the last 3 months
4. History of \>1 DKA event in the last 6 months not related to illness, infusion set failure, or initial diagnosis
5. History of chronic renal disease or currently on hemodialysis
6. History of adrenal insufficiency
7. Hypothyroidism that is not adequately treated
8. Use of oral or injectable steroids within the last 8 weeks
9. Known, ongoing adhesive intolerance
10. Plans to receive blood transfusions or erythropoietin injections during the course of the study
11. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk (specified in the study procedure manual)
12. Currently using any closed-loop system, or using an insulin pump that is incompatible with use of the study CGM
13. Participation in another pharmaceutical or device trial at the time of enrollment or during the study
14. Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial <Conditions:>Type 1 Diabetes <Interventions:>Tandem t:slim X2 with Control-IQ Technology Pro, Standard Care (SC), Tandem t:slim X2 with Control-IQ Technology V1.5 | 'Age, Continuous', 'Age, Customized', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Region of Enrollment', 'Diabetes Duration', 'Glycosylated Hemoglobin (HbA1c) at Randomization', 'Insulin Modality', 'Prior Continuous Glucose Monitor (CGM) Use', 'Annual Household Income', 'Parent Education' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Effect of Sitagliptin on Short-Term Metabolic Dysregulation of Oral Glucocorticoid Therapy <BriefSummary:>The investigators hypothesize that sitagliptin will significantly reduce impairments in insulin secretion and insulin resistance resulting from short-term oral glucocorticoid therapy. <EligibilityCriteria:>Inclusion Criteria:
* Men and women
* impaired fasting glucose
* We will stratify for weight and age.
Exclusion Criteria:
* Known Type 2 DM
* Severe disease preventing participation in study
* On chronic steroids for any reason
* Already taking DPP-4 inhibitor <Conditions:>Pre-diabetes, Impaired Fasting Glucose, Impaired Glucose Tolerance <Interventions:>Dexamethasone 2.5 mg and Sitagliptin 100 mg, Dexamethasone 2.5 mg and placebo tablet | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy <BriefSummary:>The purpose of this study is to evaluate clinical effectiveness and safety of golimumab with methotrexate (MTX) in the treatment of rheumatoid arthritis (RA) when compared to MTX alone. <EligibilityCriteria:>Inclusion Criteria:
* Diagnosis of rheumatoid arthritis (RA) for at least 3 months prior to screening
* Have been treated with and tolerated methotrexate (MTX) at a dose of at least 15 mg/week for at least 3 months prior to screening, and have been on a stable MTX dose of 15 mg/week to 25 mg/week for at least 4 weeks prior to screening
* Have an active RA, as defined by disease activity with at least 6 swollen and 6 tender joints, at the time of screening and at baseline
* C-Reactive Protein greater than or equal to 1.0 mg/dL at screening
* No history of latent or active tuberculosis prior to screening
Exclusion Criteria:
* Other inflammatory diseases, including but not limited to psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, or lyme disease
* Treated with disease modifying agents (other than methotrexate)/systemic immunosuppressives (eg, D-penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold, sulfasalazine, leflunomide, azathioprine, cyclosporine, mycophenolate mofetil) during the 4 weeks prior to first administration of study agent
* Received intra-articular (in the joint), intramuscular (in the muscle), or intravenous corticosteroids, including adrenocorticotropic hormone, during the 4 weeks prior to first administration of study agent
* Known allergy to human immunoglobulin proteins or other components of golimumab
* Received any commercial or investigational anti-tumor necrosis factor alpha therapy such as but not exclusively infliximab, golimumab, adalimumab or etanercept <Conditions:>Arthritis, Rheumatoid <Interventions:>Golimumab, Placebo, methotrexate (MTX) | 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Human Papillomavirus (HPV) Types Present in External Genital Warts (EGW) in the Argentinean Population <BriefSummary:>The summary of this study is to know which HPV types are present in genital warts in Argentinean population. <EligibilityCriteria:>Inclusion Criteria:
* women between 15 and 45 years old, with External Genital Warts
Exclusion Criteria:
* women taking corticoid therapy, having an immunosuppressed disease, pregnancy, cancer related to HPV, VIN confirmed by histology, other sexually transmitted infection, HIV+ known <Conditions:>Condylomata Acuminata <Interventions:>No Interventions | 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>IMPROVE HF: Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting <BriefSummary:>The purpose of this study is to characterize current management of patients with either heart failure or prior myocardial infarction and left ventricular dysfunction and to assess the effect of education, specific clinical guidelines, reminder systems, comprehensive disease state management tools, benchmarked quality reports, and academic detailing on the use of evidence-based heart failure therapies in cardiology practices. This study is a quality improvement initiative that is being conducted through review of patient records. <EligibilityCriteria:>Inclusion Criteria:
* 18 years of age or older
* Primary or secondary diagnosis of heart failure or prior myocardial infarction (heart attack)
* Moderate-to-severe left ventricular dysfunction (LVD) as demonstrated by an ejection fraction \< or = 35% and/or a qualitative assessment of LVD of moderate-to-severe or severe LVD
* Patient has been seen at the clinic at least twice in the past 2 years
* Patient received care from the physician participating in the study
Exclusion Criteria:
* Patient has died
* Patient is not expected to survive for 12 months due to medical conditions other than heart failure
* Patient has undergone heart transplant surgery <Conditions:>Heart Failure, Congestive, Myocardial Infarction, Ventricular Dysfunction, Left <Interventions:>No Interventions | 'Age, Continuous', 'Age, Customized', 'Sex/Gender, Customized', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Cinacalcet Hydrochloride in Treating Men With Recurrent Prostate Cancer <BriefSummary:>This phase II trial is studying how well cinacalcet hydrochloride works in treating men with recurrent prostate cancer. Cinacalcet hydrochloride may be effective in lowering prostate-specific antigen (PSA) levels in patients with recurrent prostate cancer that has not responded to previous treatment <EligibilityCriteria:>Inclusion Criteria:
* Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate
* For patients who have recurrent disease following surgery as first line therapy ("surgical failures")
* PSA requirement is 0.2 ng/ml or above
* For patients who have recurrent disease following radiation as first line therapy, the eligibility follows the "Phoenix criteria", that is, a rise of 2 ng/mL over the PSA nadir
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Granulocytes \>= 1000/uL
* Serum creatinine =\< 2.0 mg/dl
* Total serum calcium \> 9.0 and \< 10.5 mg/dl
* Total bilirubin =\< 2.0 mg/dl
* Platelet count \>=100,000/uL
* Hemoglobin (Hgb) \>= 9 g/dL
* Total testosterone \>= 50 ng/dL
* Ability to understand and the willingness to sign a written informed consent document (either directly or via a legally authorized representative)
Exclusion Criteria:
* Serious medical illness which would limit survival to less than 3 months
* Active, uncontrolled bacterial, viral or fungal infection
* Hemorrhagic disorder
* Any radiographic evidence of metastatic disease including positive bone scan or computed tomography (CT) abdomen/pelvis
* History of hypocalcemia or seizure disorder
* Patients with known hypersensitivity to any of the components of cinacalcet (cinacalcet hydrochloride) <Conditions:>Adenocarcinoma of the Prostate, Recurrent Prostate Cancer <Interventions:>laboratory biomarker analysis, quality-of-life assessment, questionnaire administration, cinacalcet hydrochloride | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A 12-week Safety and Efficacy Study of Beclomethasone Dipropionate (80 and 160 mcg/Day) Delivered Via Breath-Actuated Inhaler (BAI) in Patients >=12 Years Old With Persistent Asthma <BriefSummary:>This is a randomized, double-blind, placebo-controlled parallel-group study. Participants will be randomly assigned to receive treatment with beclomethasone dipropionate at a dosage of 80 or 160 mcg/day delivered via a Breath-Actuated Inhaler (BAI); or a matching BAI placebo, in a 1:1:1 ratio after a 14- to 21-day run-in period. Participants and investigators will remain blinded to randomized treatment assignment during the study <EligibilityCriteria:>Inclusion Criteria:
* Severity of Disease: The patient has persistent asthma, with an forced expiratory volume in 1 second (FEV1) 40%-85% of the value predicted for age, height, sex, and race as per the National Health and Nutrition Examination Survey (NHANES III) reference values at screening visit (SV) (Hankinson et al 1999).
* Current asthma therapy: The patient is currently being treated with 1 of the following:
1) inhaled corticosteroids (ICSs) at a stable daily dose of less than or equal to 220 mcg/day fluticasone propionate via metered dose inhaler (MDI) or equivalent for a minimum of 4 weeks (28 days) before screening visit, or 2) a stable daily dosage of non-corticosteroid therapy, including leukotriene modifiers, theophylline, chromones, or short-acting beta-2 agonists (SABAs) alone or in combination for a minimum of 4 weeks (28 days) before screening visit (SV).
* Reversibility of disease: The patient has demonstrated at least 15% and at least 200 mL increase from baseline FEV1 (patients age 18 and older) within 30 minutes after 2-4 inhalations of albuterol/salbutamol hydrofluoroalkane (HFA) MDI (90 mcg ex-actuator) or equivalent at SV or on retesting. - Other criteria apply, please contact the investigator for more information
Exclusion Criteria:
* The patient has a history of life-threatening asthma, defined for this protocol as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest, or hypoxic seizures.
* The patient is a pregnant or lactating female or plans to become pregnant.
* The patient has a known hypersensitivity to any corticosteroid or any of the excipients in the study drug or rescue medication formulation.
* The patient currently smokes or has a smoking history of 10 pack-years or more (a pack-year is defined as smoking 1 pack of cigarettes/day for 1 year). The patient may not have used tobacco products within the past year.
* The patient has had an asthma exacerbation requiring oral corticosteroids within 1 month before SV, or has had any hospitalization for asthma within 2 months before SV.
* The patient has historical or current evidence of a clinically significant disease. Significant disease is defined as any disease that in the medical judgment of the investigator would put the safety of the patient at risk through participation or that could affect the efficacy or safety analysis if the disease/condition worsened during the study.
* Other criteria apply, please contact the investigator for more information <Conditions:>Persistent Asthma <Interventions:>Beclomethasone dipropionate breath-actuated inhaler, Placebo breath-actuated inhaler, albuterol/salbutamol | 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Weight', 'Height', 'Body Mass Index', 'Duration of Asthma', 'Current Asthma Therapy' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Safety and Immunogenicity of Different Dosages of High-Dose Quadrivalent Influenza Vaccine in Children 6 Months to 17 Years of Age <BriefSummary:>The objectives of this study were:
* To describe the safety of each dosage of high-dose quadrivalent influenza vaccine (QIV-HD) used in the study during the 28 days following each vaccination, and serious adverse events (including adverse events of special interest throughout the study).
* To describe the antibody response induced by each dosage of QIV-HD used in the study compared with unadjuvanted standard-dose quadrivalent influenza vaccine (QIV-SD) by hemagglutination inhibition (HAI) measurement method.
* To describe the antibody response induced by each dosage of QIV-HD used in the study compared with unadjuvanted QIV-SD by virus seroneutralization (SN) measurement method.
* To describe the antibody response induced by the highest acceptable dosage of QIV-HD compared with adjuvanted trivalent influenza vaccine (TIV) by HAI and virus SN measurement methods. <EligibilityCriteria:>Inclusion criteria :
* Aged 6 months to 17 years on the day of inclusion.
* Assent form was signed and dated by the participant (7 to 17 years of age) and informed consent form was signed and dated by the parent(s) or guardian(s) and by an independent witness, if required by local regulations.
* Participant and parent/guardian were able to attend all scheduled visits and complied with all study procedures.
* For participants aged \<24 months: Born at full term of pregnancy (greater than or equal to \[\>=\] 37 weeks) and/or with a birth weight \>=2.5 kilogram.
Exclusion criteria:
* Participant was pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination. To be considered of non-childbearing potential, a female must be pre-menarche.
* Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
* Receipt of any vaccine in the 30 days preceding the first study vaccination, or planned receipt of any vaccine before Visit 3 for participants receiving 1 dose of influenza vaccine or Visit 5 for participants receiving 2 doses of influenza vaccine.
* For previously influenza vaccinated participants: Previous vaccination against influenza in the preceding 6 months with either the study vaccine or another vaccine.
* For previously influenza unvaccinated participants: Any influenza vaccination (from birth to the day of inclusion) with either the study vaccine or another influenza vaccine.
* For previously influenza unvaccinated participants: Any previous laboratory confirmed influenza infection (from birth to the day of inclusion)
* Receipt of immune globulins, blood or blood-derived products in the past 3 months.
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances.
* Thrombocytopenia or bleeding disorder, contraindicating IM vaccination based on Investigator's judgement.
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
* Current alcohol abuse or drug addiction.
* Chronic illness that, in the opinion of the investigator, was at a stage where it might interfere with study conduct or completion.
* Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature \>=38.0°Celsius \[\>=100.4°Fahrenheit\]). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided.
* Identified as an immediate family member (i.e., spouse, natural or adopted child, grandchild, nephew, or niece) of the Investigator or employee with direct involvement in the proposed study.
* Personal history of Guillain-Barré syndrome.
* Any condition that in the opinion of the Investigator would pose a health risk to the participant if enrolled or could interfere with the evaluation of the vaccine
* Personal history of clinically significant development delay (at the discretion of the Investigator), neurologic disorder, or seizure disorder.
* Known seropositivity for hepatitis B or hepatitis C.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial. <Conditions:>Influenza <Interventions:>High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 30 μg (split-virion, inactivated), High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 45 μg, (split-virion, inactivated), High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 60 µg (split-virion, inactivated), Fluarix Quadrivalent Influenza vaccine (Unadjuvanted QIV-SD) (Inactivated), FLUAD Pediatric (adjuvanted TIV) (Surface Antigen, Inactivated) | 'Age, Continuous', 'Age, Customized', 'Sex: Female, Male', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Phase III Study to Assess the Long Term Efficacy, Carry-over Effect and Safety of 300 IR Sublingual Immunotherapy Tablets <BriefSummary:>A phase III study to evaluate Long term efficacy , carry-over effect and safety of 300 IR sublingual Immunotherapy (SLIT) tablets in adults patients suffering from grass pollen rhinoconjunctivitis <EligibilityCriteria:>Inclusion Criteria:
* Male or female outpatients aged 18 to 50 years
* Grass pollen-related allergic rhinoconjunctivitis for at least the last two pollen seasons
* Positive SPT and specific IgE values of at least Class 2 for grass pollen allergens
* A score of greater than or equal to 12 out of a possible 18 on the Retrospective Rhinoconjunctivitis Total Symptom Score (RRTSS)
Exclusion Criteria:
* Patients with symptoms of rhinoconjunctivitis during the grass pollen season due to sensitisation to allergens other than grass pollen must not be included. Patients must be asymptomatic to all other allergens during the grass pollen season. Patients who have allergic rhinitis due to perennial allergen may not be included.
* Asthma requiring treatment other than beta-2 inhaled agonists.
* Patients who have received any desensitisation treatment for grass pollen or with any other allergen within the previous 5 years. <Conditions:>Allergy <Interventions:>300 IR (4M), 300 IR (2M), Placebo | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Evaluation of the Conversion From Peginesatide to Epoetin Alfa in Patients Receiving Hemodialysis <BriefSummary:>The purpose of this study is to evaluate whether hemodialysis patients on peginesatide can be converted to epoetin alfa by using a predefined conversion table while achieving a stable hemoglobin. <EligibilityCriteria:>Key Inclusion Criteria:
* Receiving hemodialysis 3 times a week
* Receiving epoetin alfa IV 3 times a week
* Hemoglobin concentration ≥ 9.0 and ≤ 12.0 g/dL within 8 weeks of or during screening
Key Exclusion Criteria:
* Systemic hematologic disease
* Changes in Epoetin alfa dose by ≥ 50% within 8 weeks of or during screening <Conditions:>Anemia <Interventions:>Peginesatide, Epoetin alfa | 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Personalized Warfarin Dosing by Genomics and Computational Intelligence <BriefSummary:>This study will create a computer program that can be used to help dose a drug called warfarin for the prevention of blood clotting. The study will collected specific information about those patients receiving this drug and use that information to create a computer program that will predict the effects of the drug. With this prediction program in place, the investigators can perform a series of "what if I gave this amount of drug" simulations to determine the best dose of drug for that patient. Once the computer programs are developed, the investigators will test the program in patients that actually need this drug. They will also include genetic information into the prediction since it has been shown that this information can affect how well the drug works. Patients will have this genetic information determined during this study. <EligibilityCriteria:>Inclusion Criteria:
* Warfarin therapy
* Attend anticoagulation clinic
* Warfarin therapy for 6 months
Exclusion Criteria:
* History of non-compliance <Conditions:>Venous Thrombosis, Atrial Fibrillation, Myocardial Infarction <Interventions:>Genomics | 'Age, Categorical', 'Sex: Female, Male', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Endoscopic Ultrasound-guided Celiac Plexus Neurolysis (EUS-CPN)With Alcohol in Unresectable Pancreatic Cancer: a Pilot Study <BriefSummary:>The purpose of this study is to obtain preliminary safety and efficacy data after endoscopic ultrasound-guided celiac plexus neurolysis (EUS-CPN) in patients with locally advanced or unresectable pancreatic adenocarcinoma.
Hypotheses:
1. Increased amounts of alcohol used in EUS-CPN is safe and more efficacious in improving pain relief in patients with locally advanced or unresectable pancreatic adenocarcinoma.
2. Effective pain relief obtained from EUS-CPN will be related to better quality of life (QOL) <EligibilityCriteria:>Inclusion Criteria:
* A total of 20 consecutive subjects with locally advanced or unresectable pancreatic adenocarcinoma (stage II to IV) with pain (abdominal and/or back). Subjects with known or suspected unresectable pancreatic adenocarcinoma will be recruited for this study, as a diagnosis of unresectable pancreatic adenocarcinoma is often made during the endoscopic ultrasound (EUS) procedure.
* Subjects must have documented disease by computed tomography (CT), endoscopic retrograde cholangio-pancreatography (ERCP), or EUS.
* Subjects undergoing EUS for pancreatic cancer staging.
* Subjects undergoing pancreatic cancer surgery are eligible for study entry beginning 5 days after the operation if they have not had an intraoperative celiac plexus neurolysis.
* No evidence of dementia or altered mental status that would prohibit the giving and understanding of informed consent, and no evidence of psychiatric risk that would preclude adequate compliance with this protocol.
Subjects must not have a coagulopathy (platelet \<50,000, INR\>1.5, or bleeding disorder, or on blood thinners) Subjects with platelets below 50,000 will not be eligible to participate in this study due to the risk of bleeding. Patients will be asked to discontinue use of non-steroidals for 5 days prior to the procedure. Patients on plavix will be asked to discontinue use for 7 days prior to the procedure if they are clinically able to do so. Patients on coumadin or lovenox will also need to discontinue use prior to the procedure, but decisions regarding their management will be made on an individual basis as per our usual standards of care.
* Subjects must provide signed written informed consent.
* A baseline pain score is not required, however, subjects must be having pain that is requiring a stable dose of pain medication for control of pain.
Exclusion Criteria:
* Subjects will be excluded if they have undergone a celiac plexus neurolysis (endoscopic, percutaneous, or surgical).
* Presence of an implanted epidural or intrathecal analgesic therapy. Subjects with psychiatric illness that affects their ability to assess quality of life or compliance with the protocol.
* Subjects with uncorrectable coagulopathy
* Subjects with an allergy to bupivacaine or alcohol.
* Presence of an aneurysm in the abdominal aorta, celiac trunk, or superior mesenteric artery. <Conditions:>Pancreatic Cancer <Interventions:>dehydrated alcohol | 'Age Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>SANICS II Trial: Stimulation of the Autonomic Nervous System in Colorectal Surgery by Perioperative Nutrition <BriefSummary:>The main objective is to investigate the effects of perioperative nutrition on postoperative ileus and anastomotic leakage in patients undergoing colorectal surgery.
Perioperative enteral nutrition is compared to the standard of care (fasting perioperatively). <EligibilityCriteria:>Inclusion Criteria:
* patients that undergo elective surgical resection of the colon or rectum with primary anastomosis.
* written informed consent
* age \>18 years
Exclusion Criteria:
* use of medication that disrupts acetylcholine metabolism
* steroid use
* previous gastric or esophageal resection
* peritoneal metastases found during surgery
* ileostomy <Conditions:>Postoperative Ileus, Anastomotic Leak <Interventions:>enriched enteral nutrition, standard | 'Age, Continuous', 'Sex: Female, Male', 'Race and Ethnicity Not Collected', 'Region of Enrollment', 'BMI', 'smoking currently', 'use of alcohol currently', 'use of neoadjuvant therapy for resection' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Eszopiclone and Inflammatory Mediators in Patients With Acute Coronary Syndrome <BriefSummary:>The purpose of the study is to examine the effects of Eszopiclone, a sleep aid, on inflammatory mediators and coagulability in patients with a recent myocardial infarction. <EligibilityCriteria:>Inclusion Criteria:
* Patients with recent (less than or equal to 8 weeks) "uncomplicated" acute myocardial infarction, can either be ST elevation MI (STEMI) or non-ST elevation MI (non-STEMI) and subsequent to successful treatment (percutaneous revascularization or medical therapy).
Exclusion Criteria:
* Obstructive sleep apnea (OSA, defined as apnea-hypopnea index \> 15 per hour) or previous diagnosis of OSA.
* Patients with life-threatening arrhythmias (such as atrial fibrillation/flutter with hypotension, ventricular tachycardia, or ventricular fibrillation, or significant heart block that requires pacing \[Type III, Type IIb\]), cardiogenic shock, severe heart failure requiring high levels of inspired oxygen (FiO2 \>40%), persistent chest pain despite medical or other interventions, and patients who are considered too unstable to participate for other medical reasons or complications (such as concomitant strokes, retroperitoneal hematoma, gastro-intestinal bleeding). Also excluded are patients with history of cardiac arrest during the same hospitalization.
* Unable to take oral medications
* Use of other sedative-hypnotics
* Hypersensitivity to Eszopiclone or any component of the formulation
* Pregnancy <Conditions:>Acute Coronary Syndrome, Sleep Disorder <Interventions:>Eszopiclone, Placebo | 'Age, Categorical', 'Age, Continuous', 'Gender', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer <BriefSummary:>The main purpose of the study is to examine if periadjuvant (neoadjuvant, then adjuvant) immunotherapy will prolong event free survival in participants with early stage non-small cell lung cancer. <EligibilityCriteria:>Inclusion Criteria:
* Participants with suspected or histologically confirmed Stage IIA (\> 4 cm) to IIIB (T3N2) non-small cell lung carcinoma (NSCLC) with disease that is considered resectable
* No brain metastasis
* Treatment-naive for NSCLC (no prior systemic anti-cancer treatment)
* Ability to provide surgical or biopsy tumor tissue for biomarkers
* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1
Exclusion Criteria:
* Participants with an active, known or suspected autoimmune disease
* Any positive test for hepatitis B virus or hepatitis C virus or human immunodeficiency virus (HIV)
* Any previous anti-cancer treatment including cytotoxic, IO treatment, targeted agents, or radiotherapy for NSCLC
* Prior treatment with any anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
Other protocol-defined inclusion/exclusion criteria apply <Conditions:>Carcinoma, Non-Small-Cell Lung <Interventions:>Nivolumab, Carboplatin, Cisplatin, Paclitaxel, Pemetrexed, Placebo, Docetaxel | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Bazedoxifene/Conjugated Estrogens (BZA/CE) Improvement of Metabolism (BIM) <BriefSummary:>The goal of this pilot clinical study is to perform a randomized placebo-controlled study to assess the beneficial effect of a 3 month-treatment with Bazedoxifene/Conjugated Estrogens (BZA/CE) vs. placebo on glucose homeostasis and body composition in 20 post-menopausal women. The recruitment will be performed at Tulane Health Sciences Center. <EligibilityCriteria:>Inclusion Criteria:
* Post-menopausal women (\<5y since final menstrual period) with age between 50-60y
* Symptomatic (hot flashes, vaginal dryness) or asymptomatic
* BMI 26-45 kg/m2 (Overweight, Obesity I and Obesity II)
* Fasting glucose \<125mg/dl
* Triglycerides \<200mg/dl
* Normal mammogram within past 12 months
* Physician clearance
Exclusion Criteria:
* Amenorrhea from other causes (Hyperandrogenemia and anovulation)
* type 2 and type 1 diabetes
* Medications: diabetes or diabetic drugs, dyslipidemia, estrogen/progestin therapy, antidepressants and antipsychotics, antiretroviral (HIV), oral steroids, weight loss drugs
* ≤ 3 month washout of birth control pill (often prescribed for postmenopausal symptoms)
* Hysterectomy (partial or complete)
* Contraindications to estrogen treatment (unusual vaginal bleeding, blot clots, hepatic disease, bleeding disorder, past/present history of breast or uterine cancer, pregnant, breastfeeding) <Conditions:>Obesity, Glucose Homeostasis, Postmenopausal Symptoms <Interventions:>Bazedoxifene/Conjugated Estrogens (BZA/CE), Placebo Oral Tablet | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Region of Enrollment', 'Years since last menstrual period (LMP)', 'Waist-to-hip ratio', 'Body Mass Index (BMI)', 'Waist circumference', 'Fasting glucose', 'Total cholesterol', 'High-density lipoprotein (HDL)', 'Low-density lipoprotein (LDL)', 'Triglycerides' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Comparing Vasopressin and Adrenaline in Patients With Cardiac Arrest <BriefSummary:>The effectiveness of medications in cardiac arrest has been greatly debated and questioned. Historically intravenous adrenaline has been the drug of choice since 1906. There have been few formal evaluations to determine the value of adrenaline for cardiac arrest, and clinical trials have not been able to show any benefit with intravenous adrenaline (compared to placebo or no treatment) in the field.
Thus the purpose of this study is to compare vasopressin and adrenaline in the treatment of cardiac arrest to answer the question whether there is an improvement in survival between vasopressin and adrenaline. <EligibilityCriteria:>Inclusion Criteria:
* Patient with cardiac arrest as confirmed by the absence of a pulse, unresponsiveness and apnea
* Age above 16 (Age 21 and above for CGH only)
Exclusion Criteria:
* Traumatic cardiac arrest
* Age 16 and below (Age 20 and below for CGH only)
* CPR is contraindicated <Conditions:>Cardiac Arrest <Interventions:>Adrenaline, Vasopressin | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Dipyridamole to Prevent Coronavirus Exacerbation of Respiratory Status (DICER) in COVID-19 <BriefSummary:>The most severe manifestations of COVID-19 include respiratory failure, coagulation problems, and death. Inflammation and blood clotting are believed to play an important role in these manifestations. Research in humans has shown that dipyridamole can reduce blood clotting. This research study is being conducted to learn whether 14 days of treatment with dipyridamole will reduce excessive blood clotting in COVID-19.
This study will enroll participants with confirmed coronavirus (SARS-CoV)-2 infection that are admitted. Eligible participants will be randomized to receive dipyridamole or placebo for 14 days in the hospital. In addition, data will be collected from the medical record, and there will also be blood draws during the hospitalization. <EligibilityCriteria:>Inclusion Criteria:
* Willing and able to provide informed consent prior to performing study procedures unless they have a legally authorized representative (LAR)
* Confirmed coronavirus (SARS-CoV-2) infection
* Currently hospitalized or anticipated hospitalization requiring supplemental oxygen
Exclusion Criteria:
* In the opinion of at least two investigators, unlikely to survive for \>48 hours from screening
* Concurrent enrollment in a clinical trial with a cytokine inhibitor (targeting interleukin-6 (IL-6), Interleukin-6 Receptor (IL-6R), IL-1, or Janus kinase). Use of remdesivir is permitted.
* Currently on invasive mechanical ventilation.
* Hypotension defined as systolic blood pressure \< 90 mmHg on two sequential readings at least 4 hours apart
* Pregnant or breastfeeding
* Concurrent dual antithrombotic therapy (aspirin or P2Y12 inhibitor plus anticoagulation to treat deep venous thrombosis or pulmonary embolism (single antiplatelet or anticoagulant agent at prophylaxis or therapeutic dose is permitted)
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 5 times upper limit of normal, hemoglobin \< 8 grams per deciliter (g/dL), or platelets \<50,000 per cubic millimeter (mm3)
* History of recent major bleeding, defined in accordance with the criteria of the International Society on Thrombosis and Hemostasis (ISTH).
* Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient by their participation in the study <Conditions:>COVID, Corona Virus Infection, Covid-19, SARS-CoV-2 Infection <Interventions:>Dipyridamole 100 Milligram(mg), Placebo oral tablet | 'Age, Categorical', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'D-Dimer', 'Oxygen Saturation (SpO2)/Fraction of Inspired Oxygen (FiO2)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Exercise as an Adjuvant to Aphasia Therapy <BriefSummary:>The purpose of the study is to reveal if individuals who participate in aerobic activity demonstrate greater improvement in language abilities than patients who do not participate in aerobic activity. <EligibilityCriteria:>Inclusion Criteria:
* Post-stroke aphasia
* at least 6 months post-stroke
* at least minimally intact auditory verbal comprehension
* pre-morbidly right handed
* native English speaker
Exclusion Criteria:
* contraindications for fMRI (metal implants, claustrophobia)
* inability to pass an exercise tolerance test
* significant depression
* uncorrected hearing or vision problems
* severe apraxia of speech
* regularly perform 20 minutes of cardiovascular exercise 3 times per week <Conditions:>Aphasia <Interventions:>Aerobic exercise, Stretching | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment', 'Boston Naming Test', 'Western Aphasia Battery' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Combination Bupropion / Varenicline for Smoking Cessation in Male Smokers <BriefSummary:>Previous results from the investigators' Center have shown that combination treatment with Chantix and Zyban is more successful in helping men quit smoking. The investigators hope to replicate these findings with this study. <EligibilityCriteria:>Inclusion Criteria:
* Have no known serious medical conditions;
* Male;
* Are 18-65 years old;
* Smoke an average of at least 10 cigarettes per day;
* Have smoked at least one cumulative year;
* Have an expired air carbon monoxide (CO) reading of at least 10ppm;
* Able to read and understand English;
* Express a desire to quit smoking in the next thirty days.
Potential subjects must agree to use acceptable contraception.
Potential subjects must agree to avoid the following:
* participation in any other nicotine-related modification strategy outside of this protocol;
* use of tobacco products other than cigarettes, including pipe tobacco, cigars, e-cigarettes, snuff, and chewing tobacco;
* use of experimental (investigational) drugs or devices;
* use of illegal drugs;
* use of opiate medications.
Exclusion Criteria:
* Hypertension;
* Hypotension with symptoms;
* Coronary heart disease;
* Lifetime history of heart attack;
* Cardiac rhythm disorder (irregular heart rhythm);
* Chest pains (unless history, exam, and electrocardiogram (ECG) clearly indicate a non-cardiac source);
* Cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
* History of skin allergy;
* Active skin disorder (e.g., psoriasis) within the last five years;
* Liver or kidney disorder (except kidney stones, gallstones);
* Gastrointestinal problems or disease other than gastroesophageal reflux or heartburn;
* Active ulcers in the past 30 days;
* Currently symptomatic lung disorder/disease (including but not limited to Chronic obstructive pulmonary disease (COPD), emphysema, and asthma);
* Brain abnormality (including but not limited to stroke, brain tumor, and seizure disorder);
* Migraine headaches that occur more frequently than once per week;
* Recent, unexplained fainting spells;
* Problems giving blood samples;
* Diabetes treated with insulin; non-insulin treated diabetes (unless glucose is less than 180mg/dcl and HbA1c is less than 7%);
* Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer);
* Other major medical condition;
* Current psychiatric disease (with the exception of anxiety disorders, Obsessive Compulsive Disorder (OCD) and ADHD);
* Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted suicide;
* Current depression;
* Bulimia or anorexia;
* Use of opiate medications for pain or sleep (non-opiate medication for pain or sleep will be allowed) within the past 14 days;
* Smoking more than one cigar a month.
* Alcohol abuse;
* Significant adverse reaction to nicotine patches, bupropion / Wellbutrin / Zyban or Chantix / varenicline in the past.
* Current participation or recent participation (in the past 30 days) in another smoking study at our Center or another research facility.
* Current participation in another research study.
Use (within the past 30 days) of:
* Illegal drugs (or if the urine drug screen is positive for tetrahydrocannabinol (THC), Cocaine, Amphetamine, Opiates, Methamphetamines, phencyclidine (PCP), Benzodiazepines, or Barbiturates),
* Experimental (investigational) drugs;
* Psychiatric medications including antidepressants, anti-psychotics or any other medications that are known to affect smoking cessation (e.g. clonidine);
* Smokeless tobacco (chewing tobacco, snuff), pipes or e-cigarettes;
* Wellbutrin, bupropion, Zyban, Chantix, varenicline, nicotine replacement therapy or any other smoking cessation aid. <Conditions:>Nicotine Dependence <Interventions:>Chantix, Zyban, Nicotine patches | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study of AZD4635 With Durvalumab and With Cabazitaxel and Durvalumab in Patients With mCRPC. <BriefSummary:>This is a Phase II, international, open-label, two-arm, non-randomised study of AZD4635 in participants with metastatic castration-resistant prostate cancer (mCRPC). <EligibilityCriteria:>Inclusion Criteria:
1. Histologically confirmed adenocarcinoma of the prostate.
2. Known castrate-resistant disease.
3. Evidence of disease progression ≤6 months.
4. Body weight \>30 kg at screening.
5. Willingness to adhere to the study treatment-specific contraception requirements.
6. Adequate bone marrow reserve and organ function.
7. Adequate organ function for Arm A as demonstrated by all of the following laboratory values:
* Alanine aminotransferase (ALT) ≤2.5 × upper limit of normal (ULN) if no demonstrable liver metastases or ≤5 × ULN in the presence of liver metastases.
* Aspartate aminotransferase (AST) ≤2.5 × ULN if no demonstrable liver metastases or ≤5 × ULN in the presence of liver metastases
* Total bilirubin (TBL) ≤1.5 × ULN
* TBL ≤2.0 × ULN in the case of known Gilbert syndrome with normal direct bilirubin
8. Participants in Arm A must have received the following prior therapy:
* Maximum of 3 lines of therapy in the mCRPC setting
* Prior therapy with one or more NHAs (eg, abiraterone acetate, enzalutamide, apalutamide, darolutamide) in either hormone-sensitive or hormone-refractory settings
* Prior therapy with one or more lines of taxanes (eg, docetaxel and/or cabazitaxel)
* Alternatively, must be taxane-ineligible
* Prior therapy can be in either the hormone-sensitive or the hormone-refractory setting
9. Adequate organ function for Arm B as demonstrated by all of the following laboratory values:
* AST and/or ALT ≤1.5 × ULN
* TBL ≤ ULN
* TBL ≤2.0 × ULN in the case of known Gilbert syndrome with normal direct bilirubin
10. Participants in Arm B must have received the following prior therapy:
* Prior docetaxel (taxane) in either hormone-sensitive or hormone-refractory settings
* Received no prior cytotoxic chemotherapy other than docetaxel for prostate cancer except for estramustine and except adjuvant/neo-adjuvant treatment completed \>3 years ago.
* Prior therapy with only one NHAs (eg, abiraterone acetate or enzalutamide; prior apalutamide is not permitted) for treatment of mCRPC in either hormone-sensitive or hormone-refractory settings.
* Be suitable to receive concomitant Granulocyte-colony stimulating factor during all cycles of cabazitaxel.
* Participants who meet inclusion criteria for Arm B will be allocated preferentially to that arm until recruitment to that arm is completed.
Exclusion Criteria:
1. Active brain metastases or leptomeningeal metastases.
2. There must be no requirement for immunosuppressive doses of systemic corticosteroids for at least 2 weeks prior to study enrollment.
3. History of pneumonitis requiring corticosteroids, second malignancy that is progressing and/or received active treatment ≤3 years before the first dose of study intervention, and hypersensitivity to polysorbate-80 if allocated to cabazitaxel.
4. As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases.
5. Creatinine clearance \<40 mL/min (calculated by Cockcroft-Gault equation).
6. Prior exposure to immune-mediated therapy including.
7. Ongoing treatment with warfarin (Coumadin).
8. Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study intervention. <Conditions:>Progressive Metastatic Castrate-Resistant Prostate Cancer <Interventions:>AZD4635, Durvalumab, Cabazitaxel | 'Age, Continuous', 'Sex/Gender, Customized', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Isotonic Solutions and Major Adverse Renal Events Trial in the Non-Medical Intensive Care Unit (SMART-SURG) <BriefSummary:>The administration of intravenous fluids is ubiquitous in the care of the critically ill. Commonly available isotonic crystalloid solutions contain a broad spectrum electrolyte compositions including a range chloride concentrations. Recent studies have associated solutions with supraphysiologic chloride content with hyperchloremia, metabolic acidosis and renal vasoconstriction, acute kidney injury and renal replacement therapy, and increased mortality but no large, randomized-controlled trials have been conducted. SMART-SURG will be a large, cluster-randomized, multiple-crossover trial enrolling critically ill patients from the non-medical ICUs at Vanderbilt University from October 2015 until April 2017. The primary endpoint will be the incidence of Major Adverse Kidney Events in 30 days after enrollment (MAKE30 is the composite of death, new renal replacement, or persistent renal dysfunction at discharge). <EligibilityCriteria:>Inclusion Criteria:
* Admitted to a participating non-medical intensive care unit (ICU) at Vanderbilt University Medical Center
Exclusion Criteria:
* Age\<18 years old <Conditions:>Critical Illness, Acute Kidney Injury <Interventions:>0.9% Saline, Physiologically-balanced isotonic crystalloid | 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Clinical Trial Testing TH-302 in Combination With Gemcitabine in Previously Untreated Subjects With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma <BriefSummary:>This Phase 3 trial is a randomized, double-blind, placebo-controlled trial of gemcitabine in combination with TH-302 compared to gemcitabine in combination with placebo in subjects with locally advanced unresectable or metastatic pancreatic adenocarcinoma. Randomized subjects will receive TH-302 plus gemcitabine or gemcitabine plus placebo in 4-week cycles until there is evidence of progressive disease, intolerable toxicity, or the subject discontinues from the trial for other reasons (for example, withdrawal of consent). The primary efficacy endpoint is overall survival (OS) time. The data cut-off for statistical analyses of the primary and secondary endpoints will be reached when 508 events (deaths) will be reported. No planned interim analyses will be conducted. An Independent Safety Monitoring Board (ISMB) will provide periodic evaluations of the unblinded safety data to ensure subject safety and the validity and scientific merit of the study. A total of 660 subjects will be enrolled. <EligibilityCriteria:>Inclusion Criteria:
* At least 18 years of age
* Locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma proven by histology or cytology and previously untreated with chemotherapy or systemic therapy other than:
* Radiosensitizing doses of 5-fluorouracil;
* Radiosensitizing doses of gemcitabine if relapse occurred at least 6 months after completion of gemcitabine;
* Neoadjuvant chemotherapy if relapse occurred at least 6 months after surgical resection;
* Adjuvant chemotherapy if relapse occurred at least 6 months after completion of adjuvant chemotherapy
* Measurable disease (at least one target lesion outside of previous radiation fields) or non-measurable disease by RECIST v.1.1 criteria
* Documentation of disease progression since any prior therapy
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy of at least 3 month
* Acceptable liver, renal function and acceptable hematological status
* Other protocol defined inclusion criteria may apply
Exclusion Criteria:
* New York Heart Association (NYHA) Class III or IV congestive heart failure, myocardial infarction within 6 months prior to the date of randomization, unstable arrhythmia or symptomatic peripheral arterial vascular disease
* Symptomatic ischemic heart disease
* Known brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 3 months)
* Previous malignancy other than pancreatic cancer in the last 5 years, except for adequately treated non-melanoma skin cancer or pre-invasive cancer of the cervix
* Severe chronic obstructive or other pulmonary disease with hypoxemia
* Major surgery, other than diagnostic surgery, less than or equal to 28 days prior to the date of randomization. Subject must have completely recovered from surgery
* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
* Treatment of pancreatic cancer with radiation therapy or surgery less than or equal to 28 days prior to the date of randomization
* Prior therapy with a hypoxic cytotoxin
* Subjects who participated in an investigational drug or device trial less than or equal to 28 days prior to Day 1 of the first cycle
* Known infection with Human Immunodeficiency Virus (HIV), or an active infection with Hepatitis B or Hepatitis C
* Subjects who have exhibited allergic reactions to a structural compound similar to TH-302 or the drug product excipients or to gemcitabine or its excipients
* Other protocol defined exclusion criteria may apply <Conditions:>Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma <Interventions:>TH-302, Gemcitabine, Placebo (5 percent dextrose - D5W) | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Capecitabine, Oxaliplatin, and Radiation Therapy in Treating Patients With Stage II or Stage III Anal Cancer <BriefSummary:>RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Capecitabine may stop the growth of tumor cells by stopping blood flow to the tumor. Radiation therapy uses high-energy x-rays to damage tumor cells. Capecitabine and oxaliplatin may make tumor cells more sensitive to radiation therapy. Combining capecitabine and oxaliplatin with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving capecitabine and oxaliplatin together with radiation therapy works in treating patients with stage II or stage III anal cancer. <EligibilityCriteria:>Inclusion Criteria:
1. Previously untreated patients with histologically proven squamous cell carcinoma of the anal canal.
2. American Joint Committee on Cancer (AJCC) stage II-IIIB (TX 1-4, NX, MO).
3. Age \>/= 16 yrs old.
4. Eastern Cooperative Oncology Group (ECOG) Performance Scale (PS) 0-1.
5. Adequate organ function including: Absolute neutrophil Count (ANC) \>/= 1,500/uL, Platelets \>/= 100,000/uL, Total bilirubin \</= 1.5 \* upper limit of normal (ULN), aspartate aminotransferase (AST or SGOT)/alanine aminotransferase (ALT or SGPT) \</= 3 \* ULN, Creatinine \</= 1.5mg/dL or Creatinine Clearance (CrCL) \>/= 50 cc/min.
6. Patients may have measurable or non-measurable disease. Patients with measurable disease, as defined by the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria, have at least one lesion that can be accurately measured in at least one dimension with longest diameter to be recorded \>/= 20 mm using conventional techniques or \>/= 10 mm with spiral CT scan (with minimum lesion size no less than double the slice thickness). Lesions seen on colonoscopy or barium studies are not considered measurable lesions.
7. A negative pregnancy test in all women of child-bearing potential, within two weeks of initiating treatment.
8. The effects of oxaliplatin and capecitabine on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because cytotoxic agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
9. Ability to understand and the willingness to sign the written informed consent/authorization document.
Exclusion Criteria:
1. Prior chemotherapy with oxaliplatin, capecitabine, or 5-fluorouracil.
2. Prior radiation to the pelvis.
3. Prior surgery for anal cancer excluding prior biopsy.
4. Known history of dihydropyrimidine (DPD) deficiency.
5. Known history of hypersensitivity to platinum-containing compounds.
6. Peripheral neuropathy of \>/= grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) 3.0.
7. Calculated creatinine clearance (CrCl) \< 50 cc/min.
8. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit adherence with study requirements.
9. Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation.
10. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with oxaliplatin or capecitabine, breast feeding should be discontinued.
11. Because of the known interaction of capecitabine and coumadin, patients taking coumadin will be ineligible. Patients will be requested to discontinue coumadin and utilize Lovenox if agreeable. Patients must have discontinued coumadin for 7 days before initiating therapy.
12. No prior malignancies (excluding non-melanomatous skin neoplasms) over the past 5 years.
13. HIV-positive patients receiving combination anti-retroviral therapy are excluded from this study because of possible pharmacokinetic interactions with capecitabine or oxaliplatin. This exclusion is for patient safety since patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, and because very few HIV-positive anal canal cancer patients are seen at this institution. This hinders us from accruing enough patients to adequately test the safety of this regimen in this population.
14. Patients with symptomatic pulmonary fibrosis. <Conditions:>Anal Cancer <Interventions:>Capecitabine, Oxaliplatin, Radiation Therapy (XRT) | 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Pharmacodynamic Effects of Ribavirin in Patients With Tonsil and/or Base of Tongue Squamous Cell Carcinoma <BriefSummary:>Human papillomavirus (HPV-16) is an important factor in the development of many tonsil and/or base of tongue squamous cell cancers. Although HPV-16 is not thought to cause cancer by itself, it appears to contribute to the development of tonsil and/or base of tongue cancer in many patients. It is likely that treatment for many patients with tonsil and/or base of tongue cancer could be improved if effective therapy to control HPV-16 is developed. The investigators in this study want to learn if ribavirin shows evidence of activity against HPV-16.
Ribavirin is a pill therapy that is approved by the Food and Drug Administration (FDA) as part of the standard treatment for Hepatitis C. Laboratory experiments suggest that ribavirin might also be useful in the treatment of head and neck cancers. However, ribavirin has not yet been tested against head and neck cancer in patients. The purpose of this study is to find out the effects of ribavirin on tonsil and base tongue squamous cell cancer in patients.
The main purpose of this study is to see if ribavirin changes the expression of certain proteins related to HPV infection in the tumor. The study will also find out if ribavirin changes how the tumor appears in a PET/CT scan (positron emission tomography/computed tomography scan). <EligibilityCriteria:>Inclusion Criteria:
* Prior diagnostic surgical or core needle biopsy, with confirmation of tonsil and/or base of tongue squamous cell carcinoma that is positive for expression of p16 and phosphorylated eIF4E, as determined by the Department of Pathology at MSKCC. The biopsy may be either of the tonsil base of tongue and/or an involved neck node. 2 unstained slides and/or tissue block must be available from the initial diagnostic biopsy
* Positive expression p16 and phosphorylated eIF4E is defined as \>=30% of tumor cells with cytological and/or nuclear staining
* Age ≥ 18 and ≤ 65 years of age
* Karnofsky Performance Status ≥ 80
* Adequate organ function, as follows:
Adequate bone marrow reserve: absolute neutrophil count (ANC) ≥ 1.5 X 109/L, platelets ≥ 160 X 109/L, hemoglobin ≥ 12 g/dL Hepatic: total bilirubin within 1.5 X upper limit of normal (ULN) ; alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 X ULN (Patients with Gilbert's syndrome as the cause of hyperbilirubinemia may be eligible if total bilirubin ≤ 2.5 X UNL) Renal: Serum creatinine ≤ 1.3 mg/dL. Patients with serum creatinine \> 1.3 mg/dL may be eligible if creatinine clearance (CrCl) ≥ 55 mL/min based on the standard Cockroft and Gault formula.
* Patients of childbearing potential must have a negative serum pregnancy test within 14 days of treatment. Patients must agree to use a reliable method of birth control during and for 6 months following the last dose of study drug.
* Ability to swallow oral medication.
* Non-surgical patients: If primary radiation +/- chemotherapy (concurrent or sequential) is planned, patients must agree to undergo research biopsy after completion of ribavirin treatment.
Exclusion Criteria:
* Prior chemotherapy or radiation for tonsillar or base of tongue squamous cell cancer
* More than 10 pack-years of tobacco use
* History of hemolytic anemia or thalassemia
* Active infection or serious underlying medical condition that would impair the patient's ability to receive protocol treatment.
* Current therapeutic anticoagulation with Coumadin (warfarin)
* Current or prior treatment with ribavirin
* Known active Hepatitis B or C
* Any prior documented history of transient ischemic attack (TIA) or cerebrovascular accident (CVA)
* New York Heart Association (NYHA) Grade II or greater congestive heart failure
* Clinically significant peripheral vascular disease
* History of unstable angina or myocardial infarction (MI) within the last 3 years <Conditions:>HEAD & NECK Cancer <Interventions:>ribavirin | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Optimization and Refinement of Technique in In-Office Sinus Dilation 2 <BriefSummary:>A prospective, multi-arm, multi-center, observational post-market study of balloon sinus dilatation in the physician office setting under local anesthesia to treat patients with chronic rhinosinusitis (CRS). All products intended for use in this study have been FDA cleared for sale in the U.S.A. <EligibilityCriteria:>Inclusion Criteria:
* Male/Female, 18 year or older
* Diagnosis of Chronic Rhinosinusitis
* Planned Endoscopic Sinus surgery
Exclusion Criteria:
* Cystic Fibrosis
* Severe Polyposis
* Sinonasal tumors
* History of facial trauma precluding access to sinus ostium
* Ciliary Disfunction
* Planned non-sinus surgery (such as rhinoplasty, septoplasty, etc.)
* Pregnant or lactating female
* Inability to tolerate an awake procedure
* Participation in another investigational clinical study involving treatment for chronic rhinosinusitis <Conditions:>Sinusitis <Interventions:>Relieva Balloon Sinuplasty System | 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Single-use Efficiency Instruments With Patient Specific Technique (MyKnee®) Versus Traditional Metal Instruments With Conventional Surgical Technique <BriefSummary:>To compare economic factors and the rate of adverse events between two types of instrumentation used for total knee replacement: Single-use Efficiency Instruments with Patient Specific Technique (MyKnee®) Traditional Metal Instruments with Conventional Surgical Technique <EligibilityCriteria:>Inclusion Criteria:
* Age 18 to 75 years
* BMI ≤35
* Undergoing unilateral total knee arthroplasty due to osteoarthritis (primary or post-traumatic OA)
* Able and willing to give consent and to comply with study requirements, including follow up visit at 6 weeks
Exclusion Criteria:
* Pregnant women or those seeking to become pregnant. Pregnancy test is administered prior to surgery as part of routine care by the hospital / surgery center for all female patients of childbearing potential
* Is participating in another clinical study
* Has inflammatory arthritis
* Has knee avascular necrosis
* Has severe deformity, defined as greater than 10 degrees varus or valgus relative to the mechanical axis
* Has retained hardware in the knee that requires removal or interferes with Total Knee Arthroplasty (TKA) procedure <Conditions:>Osteoarthritis <Interventions:>Customized patient instruments, Traditional Metal Instruments | 'Age, Continuous', 'Sex: Female, Male', 'Race and Ethnicity Not Collected', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Arthralgia During Anastrozole Therapy for Breast Cancer <BriefSummary:>The purpose of this study is to describe the joint symptoms and structural joint changes under anastrozole as adjuvant treatment in postmenopausal women with early breast cancer. <EligibilityCriteria:>Inclusion Criteria:
* Post menopausal woman with a breast cancer and scheduled for an adjuvant treatment with anastrozole
* WHO performance status 0, 1 or 2
* Provision of written informed consent
Exclusion Criteria:
* Recurrence of breast cancer, inflammatory rheumatism
* treatment by chondromodulator, oral glucocorticoid, aromatase inhibitor, anti estrogen, Herceptin
* Diabetes treated by insulin
* Severe renal or hepatic disease
* Known hypersensitivity to anastrozole <Conditions:>Early Breast Cancer <Interventions:>Anastrozole | 'Age Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Study of Ruxolitinib in Pancreatic Cancer Patients (Janus 1) <BriefSummary:>Determining the efficacy, based upon overall survival, of ruxolitinib added to capecitabine for the treatment of advanced or metastatic pancreatic cancer. <EligibilityCriteria:>Inclusion Criteria:
* Histologically or cytologically confirmed adenocarcinoma of the pancreas.
* Advanced adenocarcinoma of the pancreas that is inoperable or metastatic.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
* Received 1 prior chemotherapy regimen for advanced or metastatic disease (not including neoadjuvant and/or adjuvant therapy).
* ≥ 2 weeks elapsed from the completion of previous treatment regimen and participants must have recovered or be at a new stable baseline from any related toxicities.
* Radiographically measurable or evaluable disease
* Modified Glasgow Prognostic Score (mGPS) of 1 or 2 as defined below:
1. mGPS of 1: C-reactive protein \>10 mg/L and albumin ≥35 g/L
2. mGPS of 2: C-reactive protein \>10 mg/L and albumin \<35 g/L
Exclusion Criteria:
* Received more than 1 prior regimen for advanced or metastatic disease.
* Ongoing radiation therapy, radiation therapy administered within 30 days of enrollment.
* Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization).
* Prior severe reaction to fluoropyrimidines, known dihydropyrimidine dehydrogenase deficiency (DPD), or other known hypersensitivity to active substances, including fluorouracil (5-FU), or ruxolitinib, or any of their excipients.
* Prior treatment with a JAK inhibitor for any indication. <Conditions:>Pancreatic Cancer <Interventions:>Ruxolitinib, Placebo, Capecitabine | 'Age, Continuous', 'Age, Customized', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Efficacy, Safety, and Tolerability of Valbenazine for the Treatment of Chorea Associated With Huntington Disease <BriefSummary:>This is a Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, and tolerability of valbenazine to treat chorea in participants with Huntington disease. <EligibilityCriteria:>Inclusion Criteria:
1. Have a clinical diagnosis of Huntington Disease (HD) with chorea
2. Be able to walk, with or without the assistance of a person or device
3. Participants of childbearing potential who do not practice total abstinence must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently while participating in the study until 30 days (females) or 90 days (males) after the last dose of the study drug
4. Be able to read and understand English
Exclusion Criteria:
1. Have a history of previously established therapy with a VMAT2 inhibitor, in the judgement of the investigator
2. Have difficulty swallowing
3. Are currently pregnant or breastfeeding
4. Have a known history of long QT syndrome, cardiac tachyarrhythmia, left bundle-branch block, atrioventricular block, uncontrolled bradyarrhythmia, or heart failure
5. Have an unstable or serious medical or psychiatric illness
6. Have a significant risk of suicidal behavior
7. Have a history of substance dependence or substance (drug) or alcohol abuse, within 1 year of screening
8. If taking antidepressant therapy, be on a stable regimen
9. Have received gene therapy at any time
10. Have received an investigational drug in a clinical study within 30 days of the baseline visit or plan to use such investigational drug (other than valbenazine) during the study
11. Have had a blood loss ≥550 milliliters (mL) or donated blood within 30 days before the baseline visit
12. Had a medically significant illness within 30 days before baseline, or any history of neuroleptic malignant syndrome <Conditions:>Chorea, Huntington <Interventions:>Valbenazine, Placebo | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa <BriefSummary:>This exploratory, 12-month, ascending-dose study will evaluate the safety and effects on visual function of a single injection of Brimonidine intravitreal implant in one eye of patients with Retinitis Pigmentosa. <EligibilityCriteria:>Inclusion Criteria:
* Retinitis Pigmentosa in both eyes
* Visual acuity between 20/40 to count fingers
Exclusion Criteria:
* Growth of new blood vessels in the eye
* Any intraocular surgery or laser in either eye in the last 6 months prior to Screening visit or between the Screening visit and Day 1
* Any ocular disease that can interfere with diagnosis and or assessment of disease progression
* Significant near-sightedness
* HIV
* Female patients who are pregnant, nursing, or planning pregnancy <Conditions:>Retinitis Pigmentosa <Interventions:>400 µg Brimonidine Tartrate Implant, 200 µg Brimonidine Tartrate Implant, 100 µg Brimonidine Tartrate Implant, Sham (no implant) | 'Age Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Phase 3, Multicenter Study To Evaluate The Efficacy And Safety Of MOD-4023 In Adults With Growth Hormone Deficiency <BriefSummary:>This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with GHD to assess the safety and efficacy of a long-acting, once weekly injection of modified hGH (MOD-4023). <EligibilityCriteria:>Inclusion Criteria:
* Men and women between the age of 23 to 70 years old at screening, inclusive
* GHD subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II (2007).
* No r-hGH replacement therapy or use of GH secretagogues for at least 9 months with any registered or investigational r-hGH or GH secretagogue product.
* The IGF-I level at screening ≤-1 SDS of the age and sex normal ranges according to the central laboratory measurements
* Subjects who are on a stable diet and exercise regime and do not have plans to modify their diet or exercise for at least 12 months
* Subject had a DXA screening and the results are interpretable according to the study plan.
Exclusion Criteria:
* Women who are pregnant or breast-feeding (at least 6 months delay from childbirth or lactation)
* Evidence of growth benign intracranial tumor within the last 12 months (determined by comparing a previous MRI to a new one obtained no more than 6 months prior to study entry to clarify dynamics of growth).
* History of any cancer. Exceptions to this exclusion criterion include resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision. Patients with GHD attributed to treatment of intracranial malignant lesions in childhood or adulthood (or, tumors) or leukemia may also be enrolled into the study provided that a recurrence-free survival period of at least 5 years is well documented in the study record.
* Signs of intracranial hypertension at screening
* Heart insufficiency, NYHA class \> 2 (Appendix B)
* History of overt diabetes mellitus (including currently treated, well-controlled DM) defined according to the American Diabetes Association (ADA) Criteriaa. A history of gestational diabetes, resolved after childbirth, is not exclusionary.
* History of Acromegaly <Conditions:>Adult Growth Hormone Deficiency <Interventions:>MOD-4023, Placebo | 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Region of Enrollment', 'Weight', 'BMI' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>LY353381 in Preventing Breast Cancer in Women With Hyperplasia <BriefSummary:>RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of LY353381 may be an effective way to prevent the development of breast cancer in women who have hyperplasia.
PURPOSE: Randomized phase II trial to study the effectiveness of LY353381 in preventing breast cancer in women who have hyperplasia. <EligibilityCriteria:>DISEASE CHARACTERISTICS:
* Current random fine needle breast aspiration (FNA) evidence of 1 of the following:
* Hyperplasia with atypia
* Hyperplasia without atypia but with a 10-year modified Gail risk of at least 4%
* Hyperplasia without atypia but with a BRCAPRO risk of at least 25%
* Hyperplasia without atypia but with a known mutation in BRCA1 or BRCA2
* Hyperplasia without atypia but with a history of contralateral ductal carcinoma in situ or invasive breast cancer
* FNA must have been taken during days 1-14 of the menstrual cycle for premenopausal women
* Classified as ACR class I-III on mammogram with stepwedge within past 6 months If intact uterus and/or ovaries, must have color doppler transvaginal pelvic sonogram within past 6 months showing endometrial thickening no greater than 13 mm premenopausal or no greater than 8 mm postmenopausal
* No ovarian cysts felt to be possibly or probably non-physiologic that have not resolved to gynecologist's satisfaction on repeat sonogram
* Must agree to have or have had genetic counseling and genetic testing performed for BRCA1 and BRCA2
* No active cancer (e.g., detectable disease)
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Sex:
* Female
Menopausal status:
* Any
Performance status:
* Not specified
Life expectancy:
* At least 12 months
Hematopoietic:
* Hemoglobin greater than 10 g/dL
* Granulocyte count greater than 1,000/mm\^3
* No deficiencies in protein C, protein S, or antithrombin III
* No activated protein C resistance
Hepatic:
* Albumin greater than 3.0 g/dL
* Bilirubin less than 1.5 mg/dL
* AST less than 100 U/L
* Alkaline phosphatase less than 200 U/L
Renal:
* Creatinine less than 1.5 mg/dL
Cardiovascular:
* No history of deep venous thrombosis not related to trauma or pregnancy
* No severe coronary artery disease
* No history of prior stroke
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study
* No other active cancer
* No retinal vein thrombosis
* No concurrent severe poorly controlled migraine
* No factor V Leiden mutation carrier
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* At least 12 months since prior immunotherapy
Chemotherapy:
* At least 3 months between completion of prior KUMC phase II difluoromethylornithine (DFMO) study and baseline aspiration
* At least 12 months since prior chemotherapy
Endocrine therapy:
* Must not have started or stopped hormone replacement therapy or oral contraceptives within 6 months of baseline aspiration
* Must continue all hormone replacement therapy and/or oral contraceptives that were being taken at time of baseline aspiration
* At least 12 months since prior tamoxifen, raloxifene, or other antihormonal therapy
Radiotherapy:
* At least 3 months since prior radiotherapy
Surgery:
* At least 6 months between prior oophorectomy and baseline aspiration
Other:
* At least 2 weeks since the start of other new medication that would be ingested for 1 or more months <Conditions:>Breast Cancer <Interventions:>arzoxifene, Placebo | 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment', 'Height', 'Weight', 'BMI', 'Menopause Status', 'Hormone Use', 'Age at Menarche', 'Age at First Live Birth', 'Prior Biopsy', 'Number relatives with Breast Cancer' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>S0417 Bortezomib, Thalidomide, and Dexamethasone in Treating Patients With Relapsed or Refractory Multiple Myeloma <BriefSummary:>RATIONALE: Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as thalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. It may also stop the growth of cancer by blocking blood flow to the cancer. Drugs used in chemotherapy, such as dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving bortezomib together with thalidomide and dexamethasone may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving bortezomib together with thalidomide and dexamethasone works in treating patients with relapsed or refractory multiple myeloma. <EligibilityCriteria:>DISEASE CHARACTERISTICS:
* Diagnosis of multiple myeloma (MM)
* Active disease
* Relapsed or refractory disease after ≥ 1 prior therapy for MM, that may have included autologous or allogeneic stem cell transplantation
* Relapse is defined as the occurrence of any of the following during or after prior treatment:
* Myeloma protein level increase by \> 100% from the lowest previously recorded level
* Myeloma protein level increase above the defined response criteria for partial remission
* Reappearance of any myeloma peak that had disappeared during the prior treatment
* Increase in the size and number of lytic bone lesions and/or focal lesions by x-ray, MRI, positron emission tomography, and/or CT scan
* Refractory disease is defined as no response (i.e., not achieving complete remission, remission, or partial remission) to prior therapy
* Measurable disease
* No evidence of POEMS (polyneuropathy, organomegaly, endocrinopathy, presence of M-protein, and skin changes) syndrome
* Must be registered on protocol SWOG-S0334
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-2 (unless due to bone pain)
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count \> 1,000/mm\^3
* Platelet count \> 50,000/mm\^3
Hepatic
* AST or ALT ≤ 3 times upper limit of normal (ULN)
* Bilirubin ≤ 3 times ULN
Renal
* Creatinine clearance \> 30 mL/min
Cardiovascular
* No New York Heart Association class III or IV congestive heart failure
* No myocardial infarction within the past 6 months
* No poorly controlled hypertension
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile female patients must use effective double method contraception for ≥ 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment (during and for 4 weeks after completion of study treatment for male patients)
* No blood, ova, or sperm donation during study treatment
* No active infection requiring antibiotics
* No neurotoxicity ≥ grade 2
* No diabetes mellitus
* No other serious medical or psychiatric illness that would preclude study treatment
* No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
* See Disease Characteristics
Chemotherapy
* At least 14 days since prior chemotherapy (28 days for nitrosoureas) and recovered
Endocrine therapy
* Not specified
Radiotherapy
* At least 14 days since prior radiotherapy and recovered
Surgery
* Not specified
Other
* No prior bortezomib alone or combined with thalidomide
* Concurrent participation on protocol SWOG-S0309 allowed <Conditions:>Multiple Myeloma <Interventions:>bortezomib, dexamethasone, thalidomide | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Health Belief Model Based Intervention to Increase Human Papilloma Virus (HPV) Vaccination Among College Men <BriefSummary:>The purposes of this study are to (1) identify predictors of Human papillomavirus (HPV) vaccine acceptability among college men based on the Health Belief Model through focus groups, (2) triangulate focus group results with a prior quantitative study in developing an intervention based on the Health Belief Model to enhance HPV vaccine acceptability, and (3) test the efficacy of the above intervention based on the Health Belief Model by comparing it to a knowledge-based intervention. Approximately five focus groups with ten participants in each group with college students in the ages 18-25 years will be conducted at a large Midwestern University for the qualitative piece. Data will be analyzed for categories and triangulated with previous study to develop a theory based intervention. For the quantitative piece a randomized controlled design with 45 participants in each arm (theory based intervention and knowledge based intervention) will be implemented. <EligibilityCriteria:>Inclusion Criteria:
* Males
* English speaking
* 18-25 years
* Undergraduate or graduate student at the University of Cincinnati
Exclusion Criteria:
* Females
* Under 18 years, or above 25 years
* Non- English speaking individuals
* Non-university attending students
* If already received HPV vaccination <Conditions:>HPV Vaccine Acceptability <Interventions:>HPV vaccine acceptability | 'Age, Categorical', 'Age Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Use of an Oral Beta-2 Agonist in Persons With Spinal Cord Injury <BriefSummary:>The primary purpose of this study is to determine the effect of administration of the oral beta-2 adrenergic agonist, albuterol, on respiratory muscle strength in individuals with cervical (neck) and high thoracic (upper back) spinal cord injury and to compare findings with those obtained in a demographically matched group that will receive placebo. Participation in this study will involve 12 weeks of pharmacological intervention during which participants will be randomized to receive either oral albuterol 4mg twice daily or placebo. All investigators and study participants will be blinded to randomization by our research pharmacy. Participation in the study will require study subjects to come to our lab for the total of 2 visits (at baseline and after week 12), during which a series of tests will be performed to assess their respiratory muscle strength and pulmonary function. <EligibilityCriteria:>Inclusion Criteria:
* Chronic Spinal Cord Injury (\>1 year post-injury)
* All American Spinal Injury Association (ASIA) classifications
* High Paraplegia (level of injury T1-T6)
* Tetraplegia (level of injury C2-C8, non-ventilator dependent)
Exclusion Criteria:
* history of asthma
* uncontrolled hypertension or cardiovascular disease
* those using beta-2 adrenergic agonists
* epilepsy or seizure disorder
* hyperthyroidism
* chronic corticosteroid use
* those taking monoamine oxidase inhibitors or Tricyclic antidepressants for depression
* hypersensitivity to albuterol or any of its' delete components
* pregnancy
* use of ergogenic aids or supplements with anabolic characteristics including, but not limited to:
* creatine monohydrate
* anabolic steroids (e.g., testosterone)
* growth hormone and their analogs and/or derivatives <Conditions:>Spinal Cord Injury <Interventions:>extended release beta-2 adrenergic agonist, placebo | 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Observational Registry on the HARPOON Device <BriefSummary:>To collect data on the HARPOON™ Mitral Valve Repair System for use in patients with severe degenerative mitral regurgitation due to posterior leaflet prolapse. <EligibilityCriteria:>Inclusion Criteria:
* Subjects who are clinically suitable for treatment with the HARPOON™ System, as per the Instructions for Use (IFU), will be evaluated for inclusion in the registry.
Exclusion Criteria:
* N/A <Conditions:>Severe Degenerative Mitral Regurgitation Due to Mid-segment Posterior Leaflet Prolapse <Interventions:>HARPOON Beating Heart Mitral Valve Repair System (MVRS) | 'Age, Continuous', 'Sex: Female, Male', 'Race and Ethnicity Not Collected' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study of LY3471851 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC) <BriefSummary:>The reason for this study is to determine if the study drug LY3471851 is safe and effective in adult participants with active ulcerative colitis (UC). The study treatment will last about 52 weeks. <EligibilityCriteria:>Inclusion Criteria:
* Have moderately to severely active ulcerative colitis (UC) as defined by a modified Mayo score (MMS) of 4 to 9 with an endoscopic subscore (ES) ≥2, with endoscopy performed within 14 days before baseline.
* Have evidence of UC extending proximal to the rectum (with ≥15 centimeters (cm) of involved colon).
* Have up-to-date colorectal cancer surveillance performed according to local standard.
* Participants are either one of the following:
* Have failed conventional treatments including inability to tolerate oral or intravenous corticosteroids or immunomodulators (6-mercaptopurine or azathioprine or methotrexate), or history of corticosteroid dependence (an inability to successfully taper corticosteroids without return of UC) and neither failed or demonstrated intolerance to advanced therapy (eg, tumor necrosis factor (TNF) antagonists, anti-integrin therapies, anti-IL12/23p40 therapies, Janus kinase (JAK) inhibitor) OR,
* Have failed advanced therapies such as treatment with 1 or more advance therapies (eg, tumor necrosis factor \[TNF\] antagonists, anti-integrin therapies, anti-IL12/23p40 therapies, Janus kinase \[JAK\] inhibitor) at doses approved for the treatment of UC with documented history of failure to respond to or tolerate such treatment.
* Have had an established diagnosis of UC of ≥3 months in duration before baseline which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC. Supportive endoscopy and histopathology reports must be available in the source documents.
* Women of child-bearing potential (WOCBP) must test negative for pregnancy as indicated by a negative serum pregnancy test at the screening visit followed by a negative urine pregnancy test within 24 hours prior to first exposure to study drug.
Exclusion Criteria:
* Have been diagnosed with indeterminant colitis, proctitis (colitis limited to the rectum only; less than 15 centimeter (cm) from the anal verge or Crohn's disease.
* Have received any of the following for treatment of UC: cyclosporine, tacrolimus, mycophenolate mofetil or thalidomide within 2 weeks of screening, rectally administered corticosteroids or 5-aminosalicylic acid treatments within 2 weeks of screening.
* Have had or will need abdominal surgery for UC (for example, subtotal colectomy).
* Have failed 3 or more classes of advanced therapies approved for treatment of UC (eg, tumor necrosis factor \[TNF\] antagonists, anti-integrin therapies, anti-IL12/23p40 therapies, Janus kinase \[JAK\] inhibitor).
* Have evidence of toxic megacolon, intra-abdominal abscess, or stricture/stenosis within the small bowel or colon.
* Have any history or evidence of cancer of the gastrointestinal tract
* Have myocardial infarction, unstable ischemic heart disease, stroke or heart failure within 12 months prior to screening. <Conditions:>Colitis, Ulcerative <Interventions:>LY3471851, Placebo | 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Early Discharge After Primary Percutaneous Coronary Intervention <BriefSummary:>* When Primary percutaneous coronary intervention (PPCI) is performed expeditiously and at a high-volume centre, it is the optimal approach for ST elevation myocardial infarction (STEMI) . In contrast to the clarity of how to treat STEMI, there is no clear definition for when to discharge and which patient to discharge.
* An early discharge strategy may be desired by all parties (financial health care provider, treating physician, nurse, patient, patient's relatives)involved in STEMI.
* The main goal in our study is to test the hypothesis that an early discharge strategy within 48-56 hours in patients with successful PPCI is as safe as in those patients who stay longer (96-120 hours) as of a standard procedure. <EligibilityCriteria:>Inclusion Criteria:
* Signed informed consent and subsequent written agreement of a family member (confirming good social background)
* Acute STEMI, defined as \>30 minutes of continuous typical chest pain and ST-segment elevation ≥2 mm in two contiguous electrocardiography leads and /or left bundle branch block within 12 hours of symptom onset.
* Haemodynamically stable Angiographically
* Successful PPCI procedure (TIMI 2-3 flow and %\<20 residual stenosis) and an uneventful 24 hour follow up period
* Single epicardial artery to be treated
* Telephone contact between the patient and PCI center after discharge is available 24 hours daily
Exclusion Criteria:
* Inability to consent
* Patients treated with thrombolytic agents for the index STEMI
* Cardiogenic shock,
* Stroke within a month,
* Signs of heart failure (Killip II-IV)
* Hypotension (\<100 mmHg SBP) persisting after PPCI
* Chest pain recurrence
* Clinically significant arrhythmia (requiring treatment) occurring \>6 hours after PPCI. <Conditions:>ST Elevation Myocardial Infarction <Interventions:>early discharge | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Study Evaluating Biomarkers in Patients With Colorectal Cancer and Native KRAS Treated With Chemotherapy + Cetuximab <BriefSummary:>Advanced colorectal cancer (ACRC) is a heterogeneous disease and classification of patients is nowadays inefficient. Roughly twenty per cent of patients present with favorable figures (less than 4 liver nodules and less than 5 cm) and are suitable for local treatments (surgery or local-ablative therapies). Additionally, 10-15% of patients have poor performance status (PS \>2) or are severe disabled due to geriatric syndromes or/and co-morbid diseases that preclude any treatment strategies than best supportive care alone. The rest of patients (fit patients not suitable for radical treatments) constitute the population of patients treated with palliative therapies. Despite of it not all these patients have the same prognosis. Patients with PS 0,1 and levels of LDH \<ULN (Intermediate-risk patients) have better PFS and OS irrespective of therapy in all randomized clinical trials (de Gramont et al, JCO 2000; Douillard et al, Lancet 2000; Koopman et al, 2007).
CRYSTAL trial shows a benefit in PFS (1.5 months) in RASWT of FOLFIRI plus cetuximab compared with FOLFIRI alone. Nowadays the selection of patients for cetuximab treatment is based on mutational status of KRAS, which allow to select those patients who will not respond to therapy. Other surrogate markers of activity should be also evaluated. Our hypothesis is that the suggested biomarkers will allow the selection of the patients who will benefit the most from the biweekly cetuximab treatment. <EligibilityCriteria:>Inclusion Criteria:
* Male or female, age ≥ 18 years
* Able to sign an informed consent form
* Advanced and/or metastatic colorectal cancer
* Colorectal cancer with KRAS wild type genotype
* At least one unidimensionally measurable lesion according to RECIST criteria (1.1 revised) (to be assessed ≤ 28 days prior to the study treatment)
* All patients with the following features will be included:
1. Progression free survival \> 6 months after adjuvant treatment +/- radiotherapy
2. "De novo" diagnosis of the disease
* Performance ECOG status of 0-2
* Life expectancy ≥ 3 months
* Adequate bone marrow function: neutrophils ≥1,5 x 10\^9/L; platelets ≥ 100 x 10\^9/L; hemoglobin ≥9 g/dL.
* Adequate liver, renal and hematological function as follows:
1. Adequate liver function: SGOT and SGPT 2.5 x ULN (5 x ULN in case of hepatic metastasis). Total bilirubin \< 1,5 x ULN. Alkaline phosphatase 2,5 x LSN (5 x ULN if hepatic metastasis or 10 x ULN if bone metastasis)
2. Creatinine clearance or creatinine clearance during 24 hours ≥ 50 mL/min
3. Magnesium ≥ LLN, calcium ≥ LLN
Exclusion Criteria:
* PS \> 2 or elderly patients with fragility criteria
* Previous surgery for metastasis
* Previous systemic treatment for the metastatic colorectal cancer
* Previous treatment with antibodies anti-EGFR or treatment with small-molecule EGFR tyrosine kinase inhibitors or EGFR signal transduction inhibitors. Subjects who suspend their first dose due to a reaction to the infusion can participate
* Central nervous system metastasis (except: treated subjects with asymptomatic CNS metastasis who have not received steroids within the 30 days prior to inclusion)
* Prior malignant tumor in the last 5 years, except: basal cell carcinoma of the skin or pre-invasive cervical cancer
* Unresolved toxicities from a prior systemic treatment which do not qualify the patient for inclusion
* Presence of peripheral neuropathy (degree \> 1 in the ctc version 3.0) and serious nonhealing wound, ulcer, or bone fracture
* Hormonal treatment, immunotherapy or experimental or approved antibodies/proteins ≤ 30 days before the inclusion
* Uncontrolled serious cardiovascular disease or: congestive cardiac failure NYHA lll or lV, unstable angina pectoris, myocardial infarction precedents in the past 12 months, significant arrhythmias
* Interstitial pneumonitis or pulmonary fibrosis precedents, or interstitial pneumonitis or pulmonary fibrosis signs on the thoracic CT-scan
* Treatment for systemic infection within the 14 days prior to treatment
* Acute/subacute intestinal occlusion and/or active inflammatory bowel disease or any other bowel disease producing chronic diarrhea
* Precedent of Gilbert's syndrome or dihydropyrimidine dehydrogenase deficiency
* Precedent of any disease which can increase the risks associated to the participation in the study or interfere in the study results
* Known positive test for the following infections: HIV, Hepatitis C + abnormal liver enzymes values, active chronic Hepatitis B (except Hepatitis C seropositive with normal liver enzymes)
* All concurrent diseases which can increase the toxicity risk
* The individual presents a disorder of any kind which jeopardizes their ability to give their written consent form and/or fulfill the study procedures
* Any investigational agent within 30 days before enrolment
* Pregnant or breastfeeding woman, or planning to get pregnant within the 6 months after treatment
* Surgery (excluding the diagnostic biopsy or placing of a central venous catheter)
* Woman or man of childbearing potential not consenting to use adequate contraceptive precautions during the study and 6 months after de last administration for women, and 1 month for men
* Unability to fulfill the study requirements by the patients
* Psychological, family, sociological or geographical conditions that may interfere with the fulfillment of the study protocol and the follow-up calendar <Conditions:>Colorectal Cancer <Interventions:>FOLFIRI (m), FOLFOX-6 (m), Cetuximab | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Region of Enrollment', 'Stage', 'Primary location', 'Surgery of the primary tumor', 'Performance Status (PS)', 'Number of metastatic organs' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Move Together Boston Feasibility Pilot (Sit Less, Move More App for Black Breast Cancer Survivors & At-Risk Relatives) <BriefSummary:>The purpose of this study is to develop and test a mobile app for Black/African American breast cancer survivors and their relatives, called Move Together, that promotes sitting less and moving more for better health. <EligibilityCriteria:>Inclusion Criteria:
* 1a) Key informants (for interviews)
* Members of the community/advisory groups, community health centers, or faith-based network members (e.g., Pink and Black, Faces of Faith).
* English speaking adults.
* (1b) Breast cancer survivors and relatives (for interviews)
* Self-identify as Black or African American
* Age 18 and over
* English speaking
* Female breast cancer survivor status post curative antineoplastic treatment (except ongoing hormonal treatment) with no evidence of disease, OR a first degree blood relative (parent, child, or full sibling), of any gender, of a so defined breast cancer survivor
* Self-report ever using a smart phone
* (2) Breast cancer survivors and relatives (for user testing/interviews)
* Self-identify as Black or African American
* Age 18 and over
* English speaking
* Female breast cancer survivor status post curative antineoplastic treatment (except ongoing hormonal treatment) with no evidence of disease, OR a first degree blood relative (parent, child, or full sibling), of any gender, of a so defined breast cancer survivor
* Self-report willing/able to download the app for testing on a smart phone
* Self-report willing/able to meet via Zoom for interview
* (3) Breast cancer survivors and relatives/"buddies" (for pilot testing)
* Self-identify as Black or African American
* Age 18 and over
* English speaking
* Breast cancer survivor status post curative antineoplastic treatment (except ongoing hormonal treatment) with no evidence of disease, OR a blood relative, of any gender, of a so defined breast cancer survivor
* Self-report willing/able to participate with a blood relative in survivor relative dyad
* Self-report willing/able to download the app for use on a smart phone
* Self-report willing/able to meet via Zoom for instructions and interview
Exclusion Criteria:
* (1a) Key informants (for interviews)
--None
* (1b) Breast cancer survivors and relatives (for interviews)
* Requires medically supervised physical activity (Physical Activity Readiness Question for Everyone, PAR-Q+, Question 7)
* Pregnant women
* (2) Breast cancer survivors and relatives (for user testing/interviews)
* Requires medically supervised physical activity (Physical Activity Readiness Question for Everyone, PAR-Q+, Question 7)
* Pregnant women
* (3) Breast cancer survivors and relatives/"buddies" (for pilot testing)
* Meets exclusion criterion of the Modified Physical Activity Readiness Questionnaire (PAR-Q) (modified)
* Participated in interviews or user testing in prior phases of the study <Conditions:>Breast Cancer Survivor, Breast Cancer, Fitness Trackers <Interventions:>Move Together app/Garmin Activity Tracker | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Region of Enrollment', 'Breast Cancer Status' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Real World Data on Gi(l)Otrif® Dose Adjustment <BriefSummary:>This is a non-interventional, multi-country, multi-site study based on existing data from medical records of patients treated with Gi(l)otrif® as part of the routine treatment according to the approved label. Data from real-world will help to understand if dose modifications are done similar as in LUX-Lung 3 trial and if the outcome on safety and effectiveness are as in trial settings. Furthermore, data on modified starting doses, the underlying reasons and effects on safety and outcome are needed. <EligibilityCriteria:>Inclusion criteria:
1. Age = 18 years
2. Patients with Epidermal growth factor receptor (EGFR) mutation (common mutations), tyrosine kinase inhibitors (TKI)-naïve advanced non small cell lung cancer (NSCLC), treated with Gi(l)otrif® as the first-line treatment for NSCLC within the approved label
3. Signed and dated written informed consent per regulations. (Exemption of a written informed consent for retrospective observational studies in some countries per local regulations and legal requirements.)
Exclusion criteria:
1. Any contraindication to Gi(l)otrif® as specified in label.
2. Patients with uncommon mutations are excluded as uncommon mutations are not within label in all participating countries (e.g. USA).
3. Patients still on treatment with Gi(l)otrif® will be excluded unless treatment period is \> or = 6 months.
4. Patients treated with Gi(l)otrif® within an interventional trial. <Conditions:>Carcinoma, Non-Small-Cell Lung <Interventions:>No Interventions | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Calcium and Phosphorus Whole-Body Balance and Kinetics in Patients With Moderate Chronic Kidney Disease <BriefSummary:>This pilot study aims to develop a method for simultaneous whole-body calcium and phosphorus balance and full kinetic modeling of both ions in patients with chronic kidney disease. <EligibilityCriteria:>Inclusion Criteria:
* Men or women, ages 30-75 years old, any race or ethnicity
* Moderate chronic kidney disease
* Female subjects must be postmenopausal (\>12 months since last menstrual period), surgically sterile, or confirmed not pregnant by pregnancy test
* Must be on stable doses of medications (except those noted in exclusion criteria) for at least 4 weeks prior to the study
* Willing to discontinue nutritional supplements (e.g. vitamin D, calcium, multivitamin/minerals, or others) upon enrollment until completion of the study
* Adequate vitamin D status defined as serum 25D \> 20 ng/mL
Exclusion Criteria:
* Plans to initiate dialysis within 6 months
* Hypercalcemia defined as serum calcium \>10.5 mg/dL within past 3 months
* Hyperkalemia defined as serum potassium \>5.5 mg/dL within past 3 months
* Hyperphosphatemia defined as serum phosphate \>5.5 mg/dL within past 3 months
* Intestinal disease that alters absorption or normal intestinal function including celiac disease, small bowel resection, or bariatric surgery
* Serious, uncontrolled underlying systemic disease including diabetes, lupus, hypertension
* Pregnant or breastfeeding
* Prescribed a phosphate binder medication, calcitriol, vitamin D analogs, calcimimetics, parathyroid hormone analogues, and other medications that may alter Ca and P metabolism within past 30 days <Conditions:>Phosphorus and Calcium Disorders, Chronic Kidney Disease Mineral and Bone Disorder, Chronic Kidney Diseases <Interventions:>High Phosphorus Diet, Low Phosphorus Diet | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'estimated glomerular filtration rate (eGFR)', 'body mass index (BMI)', 'Serum phosphorus', 'Serum intact fibroblast growth factor-23 (iFGF23)', 'Serum 1,25-dihydroxyvitamin D3 (1,25D)', 'Serum intact parathyroid hormone (iPTH)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Glembatumumab Vedotin in Treating Patients With Recurrent or Refractory Osteosarcoma <BriefSummary:>This phase II trial studies how well glembatumumab vedotin works in treating patients with osteosarcoma that has come back (recurrent) or does not respond to treatment (refractory). Monoclonal antibodies, such as glembatumumab vedotin, may find tumor cells and help kill them. <EligibilityCriteria:>Inclusion Criteria:
* Patients must have had histologic verification of osteosarcoma at original diagnosis or relapse
* Patients must have measurable disease according to RECIST 1.1, and have relapsed or become refractory to conventional therapy
* Patient must have archival tumor specimen available for submission
* Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2; use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age
* Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study
* Myelosuppressive chemotherapy: must not have received within 2 weeks of entry onto this study (4 weeks if prior nitrosourea)
* Biologic (anti-neoplastic agent): at least 7 days since the completion of therapy with a biologic agent
* Radiation therapy (RT): \>= 2 weeks for local palliative RT (small port); \>= 6 months must have elapsed if prior craniospinal RT or if \>= 50% radiation of pelvis; \>= 6 weeks must have elapsed if other substantial bone marrow (BM) radiation
* Monoclonal antibodies: must not have received any monoclonal based therapies within 4 weeks, and all other immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer) within 2 weeks, prior to study enrollment
* Peripheral absolute neutrophil count (ANC) \>= 1000/uL
* Platelet count \>= 75,000/uL (transfusion independent)
* Hemoglobin \>= 8.0 g/dL (may receive red blood cell \[RBC\] transfusions)
* Creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 or a serum creatinine based on age/gender as follows:
* Age 1 to \< 2 years (male and female: 0.6 mg/dL)
* Age 2 to \< 6 years (male and female: 0.8 mg/dL)
* Age 6 to \< 10 years (male and female: 1 mg/dL)
* Age 10 to \< 13 years (male and female: 1.2 mg/dL)
* Age 13 to \< 16 years (male: 1.5 mg/dL and female: 1.4 mg/dL)
* Age \>= 16 (male: 1.7 mg/dL and female: 1.4 mg/dL)
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age
* Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase \[ALT\]) \< 110 U/L; for the purposes of this study the ULN for SGPT is defined as 45 U/L
* Serum albumin \> 2 g/dL
* Shortening fraction of \>= 27% by echocardiogram, or
* Ejection fraction of \>= 50% by radionuclide angiogram
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
* Patients with \> grade 2 neuropathy according to the Modified ("Balis") Pediatric Scale of Peripheral Neuropathies will be excluded except in cases in which neuropathy is secondary to prior surgery
* Patients who have previously received CDX-011 (CR011-vc monomethyl auristatin E \[MMAE\]; CDX-011) or other MMAE-containing agents
* Patients who have received other investigational drugs within 2 weeks or 5 half-lives (whichever is longer) prior to study enrollment
* Patients with a history of allergic reactions attributed to compounds of similar composition to dolastatin or auristatin; compounds of similar composition include auristatin PHE as an anti-fungal agent, auristatin PE (TZT-1027, Soblidotin, NSC-654663) as an anti-tumor agent and symplostatin 1 as an anti-tumor agent
* Patients with known central nervous system metastasis are not eligible
* Patients who have had major surgery within 2 weeks prior to enrollment are not eligible; procedures such as placement of a central vascular catheter, or limited tumor biopsy, are not considered major surgery
* Female patients who are pregnant are ineligible
* Lactating females are not eligible unless they have agreed not to breastfeed their infants
* Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
* Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation and for 2 months after the end of study treatment <Conditions:>Recurrent Osteosarcoma <Interventions:>Glembatumumab Vedotin, Laboratory Biomarker Analysis, Pharmacological Study | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Accessible HCV Care Intervention for People Who Inject Illicit Drugs (PWID) <BriefSummary:>The proposed study will examine the feasibility, acceptability, safety, effectiveness, and cost of an Accessible Care intervention for engaging people who inject illicit drugs (PWID) in hepatitis C care. Accessible Care for PWID is low-threshold care provided in programs designed specifically for PWID where they can comfortably access care without fear of shame or stigma. Accessible Care will be provided by co-locating a hepatitis treatment provider, together with a Hepatitis C Care Coordinator (HCCC), on-site at a collaborating needle exchange program. The proposed study will compare the effectiveness of Accessible Care with Usual Care (referrals to existing services) in facilitating linkage, engagement, and retention of PWID in care for hepatitis C, addiction, and HIV prevention. The primary outcome is sustained virologic response, which constitutes virologic cure. Substance use and HIV and HCV risk behaviors are secondary outcomes. <EligibilityCriteria:>Inclusion Criteria:
1. 18 years or older,
2. injected heroin, cocaine, or other drugs in the past 90 days.
3. test HCV Ab and RNA positive
4. provide written consent (including consent for researchers to examine their hepatitis C medical records)
Exclusion Criteria:
Persons already in care for hepatitis C, defined as having had at least 2 visits with a hepatitis treatment provider within the past 6 months, will be excluded.
People with decompensated cirrhosis will be excluded. <Conditions:>Hepatitis C, People Who Inject Drugs, PWID, HCV Coinfection <Interventions:>Accessible Care, Usual Care | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race/Ethnicity, Customized', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study of IRESSA Treatment Beyond Progression in Addition to Chemotherapy Versus Chemotherapy Alone <BriefSummary:>The purpose of this study is to assess the efficacy and safety of gefitinib in patients who have progressed on first line gefitinib, comparing continuing gefitinib in addition to cisplatin plus pemetrexed combination chemotherapy versus cisplatin plus pemetrexed combination chemotherapy alone. <EligibilityCriteria:>Inclusion Criteria:
* Male or female patients aged 18 years or older (For Japan only- male or female patients aged 20 years or older)
* Cytological or histological confirmation of NSCLC other than predominantly squamous cell histology with an activating EGFR TK mutation as determined locally
* Patients with documented 'acquired resistance' on first line gefitinib
* Patients suitable to start cisplatin based pemetrexed combination chemotherapy.
* Provision of informed consent prior to any study specific procedures.
Exclusion Criteria:
* Prior chemotherapy or other systemic anti-cancer treatment (excluding gefitinib). Palliative bone radiotherapy must be completed at least 2 weeks before start of study treatment with no persistent radiation toxicity).
* Past medical history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis which required steroid treatment or any evidence of clinically active interstitial lung disease
* Other co-existing malignancies or malignancies diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ or completely resected intramucosal gastric cancer
* Any evidence of severe of uncontrolled systemic disease Treatment with an investigational drug within 4 weeks before randomization <Conditions:>Non-Small Cell Lung Cancer <Interventions:>Gefitinib, Placebo, Pemetrexed, Cisplatin | 'Age, Customized', 'Sex: Female, Male', 'Race/Ethnicity, Customized' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Sildenafil (Viagra) for the Treatment of Dyskinesias in Parkinson's Disease <BriefSummary:>This study is to determine if Viagra is effective in reducing dyskinesias in patients with Parkinson's Disease. <EligibilityCriteria:>Inclusion Criteria:
1. Diagnosis of idiopathic Parkinson's disease, Hoehn and Yahr stage 2.0 to 4.0.
2. Presence of drug-induced dyskinesias
3. Age\>40 years.
4. Willingness and ability to comply with the study requirements and give informed consent.
Exclusion Criteria:
1. Atypical parkinsonian syndrome due to drugs, metabolic disorders, encephalitis, or degenerative diseases.
2. History of stereotaxic brain surgery.
3. Clinical history of dementia.
4. Known major psychiatric disorder, major depression, schizophrenia. Known alcoholism or substance dependence within previous 12 months.
5. History of major hematological, renal, or hepatic abnormalities.
6. Known coronary artery disease including angina or myocardial infarction within the last 6 months. Significant cardiovascular disease including cardiac failure, unstable angina or life-threatening arrhythmia within the last 6 months.
7. History of stroke within the last 6 months.
8. Abnormal EKG consistent with cardiac ischemia.
9. Treatment with nitrates. Nitrates or any NO donors in any dosage form (oral, sublingual, transdermal, inhalation, or aerosols).
10. Malignant hypertension or SBP . 180 or \<90, or DBP .110 or \<50.
11. History of priapism.
12. Known history of retinitis pigmentosa.
13. Positive pregnancy test.
14. History of bleeding disorder.
15. Patients with active peptic ulcer disease associated with bleeding.
16. Unwillingness to use adequate contraceptive methods if of childbearing potential.
17. Patients with medical or psychological condition or social circumstances that would impair their ability to participate in the study.
18. Use of Viagra or any experimental drugs within 30 days of screening visit. <Conditions:>Parkinson's Disease <Interventions:>sildenafil, Placebo | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Effect of Probiotic Supplementation on the Immune System in Patients With Ulcerative Colitis in Amman, Jordan <BriefSummary:>Ulcerative colitis (UC) is a chronic Inflammatory bowel disease (IBD) that most likely results from the interaction between various environmental and genetic factors. Using probiotics as an adjunct to medical therapy might be useful in the treatment of UC and improving the symptoms of the disease. The result of studies that investigate the role of Probiotics supplementation in improving the inflammatory response, immune response and life quality of patients with the UC is not conclusive. So, this study aimed to study the effect of probiotics on the response of inflammatory markers, immune response, and quality of life in patients with UC.
An interventional double-blind randomized clinical trial (RCT) design will be used in this study. Forty patients will be recruited and randomly assigned to the placebo group (n=20) to receive 3 times a day placebo capsules; and probiotics group (n=20), to receive 3 times a day probiotic supplement. The demographic data, anthropometric measurements, IBD Quality of Life Questionnaire and blood samples will be collected at baseline and after 6 weeks of follow up. Interleukin-6, interleukin-1,interleukin-10 IL-10, C-reactive protein, tumor necrosis factor-alpha and complete blood count (CBC) will be measured.
The results will approve or disapprove the beneficial effect of using probiotics as adjuvant therapy for UC patients to raise the immune system as well as improving their quality of life. <EligibilityCriteria:>Inclusion Criteria:
* Male and female patients,
* Age between 35 -65 years,
* Diagnosed with UC established by colonoscopy and histology, and suffering from mild to moderate UC as defined by Modified Mayo Disease Activity Index (MMDAI) (score 3-9).
Exclusion Criteria:
* Patients with age \<35 years, \>65 years,
* Pregnancy, planned pregnancy, breastfeeding women,
* Evidence of severe disease (MMDAI \>10),
* Concurrent enteric infection,
* Use of antibiotics,
* Change in the dose of oral 5-aminosalicylic acid (5-ASA) within the past 4weeks, and use of rectal 5-ASA or steroids within 7 days before entry into the study,
* Received any investigational medicines within 3months,
* If they have significant hepatic, renal, endocrine, respiratory, neurological, or cardiovascular diseases <Conditions:>Ulcerative Colitis <Interventions:>Probiotic Formula Capsule, Placebos | 'Age, Categorical', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Region of Enrollment', 'Ethnicity', 'Body mass index', 'Family history of IBD', 'History of Probiotic use' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Determining the Feasibility of Spinal Cord Neuromodulation for the Treatment of Chronic Heart Failure <BriefSummary:>The purpose of this study is to determine the feasibility of spinal cord stimulation (SCS) as a chronic therapy for systolic heart failure. <EligibilityCriteria:>Inclusion Criteria:
* Left Ventricular Ejection Fraction (LVEF) of 35 percent or less
* New York Heart Association (NYHA) functional Class III at time of screening
* QRS duration less than 120 milliseconds (ms)
* Left Ventricular End Diastolic Diameter (LVEDD) of 55 millimeters (mm) to 80 mm as determined by echocardiography within the past 6 months
* Receiving stable optimal medical therapy for heart failure prior to enrollment
* Serum creatinine less than or equal to 3.0 milligrams per deciliter (mg/dL)
* 18 years of age or older
* Willing and able to comply with study procedures
* Expected lifespan greater than 12 months beyond study enrollment as assessed by physician
Exclusion Criteria:
* Interruption of thromboprophylaxis (e.g., heparin, LMWH, warfarin, aspirin, dabigatran, clopidogrel) would pose an unacceptable health risk (e.g., patient with an abnormal bleeding time), as determined by physician
* Polyneuropathy
* Requires diathermy including shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy
* Unable to perform an exercise capacity test
* Pregnant or planning to become pregnant during this study
* Currently enrolled or plans to enroll in another investigational device or drug study that may confound the results of this study
* Had Coronary Artery Bypass Graft/Percutaneous Coronary Intervention/Bare Metal Stent (CABG/PCI/BMS) procedures within the past 90 days
* Had a heart transplant
* Has complete heart block
* Had Acute Coronary Syndrome within the past 90 days
* Has congenital heart disease with significant hemodynamic shunting
* Has chemotherapy-induced heart failure
* Has reversible cardiomyopathy
* Has severe mitral regurgitation (greater than 60 percent regurgitant fraction or greater than 0.3 centimeters squared (cm2) regurgitant orifice area)
* Has diagnosed unstable angina pectoris
* Has unstable coronary artery disease
* Has a Cardiac Resynchronization Therapy (CRT) device implanted and is receiving CRT therapy
* Has a non-Medtronic Implantable Cardioverter Defibrillator (ICD), pacemaker, or any non-transvenous defibrillation lead
* Has a Medtronic ICD whose sensing threshold cannot be programmed to 0.3mV or greater
* Has an existing neurostimulator <Conditions:>Heart Failure <Interventions:>Medtronic PrimeADVANCED Neurostimulator, Medtronic PrimeADVANCED Neurostimulator | 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Immunogenicity and Safety of V419 (PR51) in Combination With MCC in Infants and Toddlers (V419-011) <BriefSummary:>The primary objectives of this study are to evaluate the immunogenicity and safety of concomitant administration of V419 (PR51) with 2 types of meningococcal serogroup C conjugate (MCC) vaccines to healthy infants at 3 and 4 months of age in terms of antibody seroprotection rate (SPR) to MCC. Participants also received a Haemophilus influenza type B (Hib)-MCC vaccination at 12 months of age. It was hypothesized that the SPR to MCC at 1 month post-dose 2 of either tetanus toxoid conjugated Meningo C (MCC-TT) or CRM197 conjugated Meningo C (MCC-CRM) vaccines would be acceptable when administered concomitantly with V419. <EligibilityCriteria:>Inclusion Criteria:
* Healthy infant 46 to 74 days of age (both inclusive)
* Parent(s)/legal representative able to comply will the study procedures
Exclusion Criteria:
* Is participating in a study with an investigational compound or device since birth
* Has a history of congenital or acquired immunodeficiency
* Has a history of leukemia, lymphoma, malignant melanoma or myeloproliferative disorder
* Has a chronic illness that could interfere with study conduct or completion
* Has hypersensitivity to any of the vaccines components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines or contraindication to any of the study vaccines
* Has a history, or mother has a history, of hepatitis B virus surface antigen (HBsAg) seropositivity
* Has a coagulation disorder that contraindicate intramuscular injection
* Has a history of vaccination with a hepatitis B, Haemophilus influenzae type b conjugate, diphtheria, tetanus, pertussis (acellular or whole-cell), poliovirus, pneumococcal conjugate or polysaccharide, meningococcal serogroup C conjugate, measles, mumps, or rubella containing vaccine(s)
* Has a history of hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliomyelitis, invasive pneumococcal, meningococcal serogroup C, measles, mumps or rubella infection
* Has received immune globulin, blood or blood-derived products, immunosuppressive agents systemic corticosteroids since birth
* Has received vaccination with an inactivated (except influenza vaccine) or conjugated or live vaccine in the last 30 days or vaccination with an inactivated influenza vaccine in the last 14 days
* Has received antipyretic, analgesic and non-steroidal anti-inflammatory medications in the last 48 hours
* Has a febrile illness or body temperature ≥38.0°C in the last 24 hours <Conditions:>Neisseria Meningitidis, Bacterial Infections, Virus Diseases <Interventions:>V419, PREVNAR 13®, MCC-TT, MCC-CRM, Hib-MCC, MMR Vaccine | 'Age, Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Treatment for Calcium Phosphate Kidney Stone Disease <BriefSummary:>The investigators will examine in two studies whether citric acid or potassium citrate can reduce calcium phosphate saturation in urine of Calcium Phosphate stone formers. <EligibilityCriteria:>Inclusion Criteria:
Aim 1
* Hypocitraturic CaP stone formers
* urine citrate \<320mg/d
* elevated pH as 24-hr urine pH above 6.40
* \>21 years
Aim 2
* Hypercalciuric CaP stone formers
* 24hr urine calcium \>250mg/d in women and \>300mg/d in men prior to indapamide use
* high pH as \>6.40 in the absence of urinary tract infection
* \>21 years <Conditions:>Calcium Phosphate Kidney Stones <Interventions:>Placebo, Citric Acid, Potassium Citrate | 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Height', 'Weight', 'Body mass index (BMI)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Study to Define the ECG Effects of Tizanidine Compared to Placebo and the Positive Control, Moxifloxacin, in Healthy Men and Women Using a Blinded ECG Evaluator: A Thorough ECG Trial <BriefSummary:>This is a single-center, partial-blind, randomized, placebo-controlled, parallel design study with a nested crossover comparison to define the ECG effects of tizanidine compared to placebo and the positive control, moxifloxacin, in healthy men and women. The study will be conducted in a Phase 1 unit with sufficient facilities to house subjects as required by the protocol. <EligibilityCriteria:>Inclusion Criteria:
* Women of childbearing potential should have a negative urine pregnancy test prior to Screening and Day -2 of the trial
* All subjects of childbearing potential must practice a highly effective method of birth control excluding oral contraceptives for the duration of the trial and up to 3 months after the last dose of investigational product. Oral contraceptives are not allowed, based on the precaution listed in the Zanaflex package insert.
* Have a body mass index (BMI) ranging between 19 and 30 kg/m2
* Comprehend and be able to provide written informed consent
* Be willing and able to comply with all trial requirements
Exclusion Criteria:
* Female who is either pregnant, breastfeeding or planning to become pregnant
* History of hypersensitivity or allergic reaction to tizanidine or moxifloxacin or any of the tablet components
* Any condition possibly affecting drug absorption, metabolism or excretion including previous surgery for removal of parts of stomach, bowel, liver, gall bladder, or pancreas
* History of Long QT Syndrome or a first-generation relative with this condition
* Evidence or history of clinically significant allergies except for untreated, asymptomatic, seasonal allergies at time of dosing, hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, renal, psychiatric, or neurological disease. Determination of clinical significance is to be made at the Investigator's discretion
* History or presence of any malignant or benign neoplasm considered by the investigator to be clinically significant
* History of drug or alcohol abuse or dependence within the last year
* Have an active infectious disease <Conditions:>Spasticity <Interventions:>Tizanidine, Placebo, Moxifloxacin | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Understanding Different Parameters in Locomotor Training (a Type of Walking Training) for Person After a Stroke <BriefSummary:>This is a research study to understand how people who have experienced a stroke walk in order to develop better and more effective types of therapy. Data collected from people who have experienced a stroke and healthy individuals will be used to compare a neurologically healthy person to someone, which has sustained an injury. <EligibilityCriteria:>Inclusion Criteria:
* adults at least 18 years old;
* able to provide informed consent;
* able to follow three-step motor command;
* have a single unilateral stroke;
* medically stable (i.e. asymptomatic for bladder infection, decubiti, osteoporosis, cardiopulmonary disease, pain, or other significant medical complications that would prohibit or interfere with walking;
* able to stand with assistance and/or ambulate 15 meters with or without an assistive device or brace and no greater than standby physical assistance.
Exclusion Criteria:
* weight \> 300 pounds due to limitations in body weight support systems;
* body size which is incompatible with harnesses;
* pregnancy;
* presence of significant musculoskeletal problems that limit hip and knee extension or ankle plantarflexion to neutral;
* self selected walking speed below 0.3 m/s; and
* history of congestive cardiac failure, unstable angina, or peripheral vascular disease. <Conditions:>Stroke <Interventions:>No Interventions | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment', 'Baseline walking speed' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Ideas Moving Parents and Adolescents to Change Together (IMPACT) <BriefSummary:>The National Heart, Lung, and Blood Institute (NHLBI) of the National Institute of Health (NIH) has sponsored a consortium of four sites across the United States, entitled Childhood Obesity Prevention and Treatment Research (COPTR). Each site has its own protocol. Case Western Reserve/Cleveland's project is entitled "Targeting Obesity and Blood Pressure in Urban Youth". The site name is IMPACT (Ideas Moving Parents and Adolescents to Change Together).
The project assesses the effects of three interventions on Body Mass Index(BMI) in overweight and obese urban 5th-8th grade youth: a cognitive-behavioral intervention (HealthyChange), a systems improvement intervention (SystemsChange), and an education-only intervention (Tools4Change). In addition the study assesses the potential additional impact of a school-community based intervention on outcomes.
The project has two phases: a formative phase (including focus groups and a pilot) and the main trial. The main trial will take place over approximately four years. <EligibilityCriteria:>Inclusion Criteria:
* Students entering the 6th grade who are found at the standard school screenings to be overweight or obese
* (BMI 85th- 94th percentile or \> 95th percentile for age/sex respectively)
Exclusion Criteria:
* Taking medications that alter appetite or weight (e.g. glucocorticoids, metformin, insulin, Risperidone (Risperdal), Olanzapine (Zyprexa), Clozapine(Clozaril), Quetiapine (Seroquel), Ziprasidone (Geodon), Carbamazepine (Tegretol), Valproic acid (Depakote/Depakene/Depacon), Aripiprazole (Abilify), Orlistat (Xenical), Sibutramine (Meridia), Phentermine, Diethylproprion (Tenuate), Topirimate (Topamax), glitazones (thiazolidinediones)
* Inability to understand English
* Stage 2 hypertension or stage 1 hypertension with end organ damage (left ventricular hypertrophy, microalbuminuria)
* Severe behavioral problems that preclude group participation (as reported by parent/guardian)
* Child involvement in another weight management program
* Family expectation to move from the region within 1 year
* The presence of a known medical condition that itself causes obesity (e.g., Prader-Willi syndrome) or interfere with HbA1C ( sickle cell disease) <Conditions:>Overweight, Obese <Interventions:>HealthyCHANGE, SystemCHANGE | 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Region of Enrollment', 'Body mass index' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Self-Defense Training in Women With Trauma <BriefSummary:>Previous research has shown that self-defense training can lead to gains in women's assertiveness, self-esteem, self-efficacy, and physical competence, and decreases in anxiety, helplessness, fear, and avoidant behaviors. However, most of this research has been conducted with healthy women who had not previously experienced physical or sexual violence. The investigators believe that women with such trauma histories require additional care because of potential triggering symptoms. As such, the investigators are mindful of the potential for triggering trauma symptoms and will work with the women so that they feel safe and comfortable in their participation. This pilot study aims to examine whether similar psychological gains from self-defense training are made in women who have previous experiences of physical and/or sexual violence. <EligibilityCriteria:>Inclusion Criteria:
1. Women ages 21-65 years
2. History of physical and/or sexual violence, with subsequent interpersonal or psychological distress (e.g., depression or anxiety) related to this history.
Exclusion Criteria:
1. Substance abuse in the past 6 months
2. Significant medical conditions that would preclude safe participation in the study
3. High levels of depression with significant suicide risk
4. Pregnant women
5. Active symptoms of psychosis or psychiatric instability
6. History of assaultive behavior or is judged to be at potential risk to assault others. <Conditions:>Depression, Anxiety, Stress Disorders, Post-Traumatic <Interventions:>Life skills and self-defense training | 'Age, Continuous', 'Gender', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter <BriefSummary:>A prospective, non-randomized study. The subjects will be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. The post-treatment follow-up visit can be up to 5 years.
The objective of the study is to evaluate the safety and efficacy of the Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter System in the treatment of BPH. <EligibilityCriteria:>Inclusion Criteria:
1. Male subject \> 50 years of age who has moderate-to-severe LUTS (IPSS score of ≥ 13) and is a candidate for interventional therapy
2. LUTS felt to be secondary to an enlarged prostate (henceforth termed LUTS/BPH)
3. Peak urinary flow rate (Qmax) ≥ 5 mL/sec and ≤ 15 ml/sec with minimum voided volume of ≥ 125 ml
4. Post-void residual (PVR) ≤ 250 ml
5. Prostate volume 20 - 80 gm as determined by TRUS
6. Prostatic urethra length is 35 - 55 mm as determined by TRUS
7. Able to complete the study protocol in the opinion of the investigator
Exclusion Criteria:
1. Interested in maintaining fertility and unwilling to use protected sex for the first 30 days post treatment
2. Unwilling to abstain or use protected sex for ninety (90) days post treatment if sexual partner is of child bearing potential
3. Presence of a penile implant or stent(s) in the urethra or prostate
4. Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
5. PSA \> 10 ng/ml unless prostate cancer is ruled out by biopsy. If PSA is \> 4 ng/ml and ≤ 10 ng/ml, prostate cancer must be ruled out to the satisfaction of the investigator via additional tests including digital rectal exam (DRE) and/or biopsy
6. Confirmed or suspected malignancy of prostate or bladder
7. Active or history of epididymitis within the past 3 months
8. Previous pelvic irradiation or radical pelvic surgery
9. Documented active urinary tract infection (UTI) by culture or bacterial prostatitis within last year documented by culture (UTI is defined as \>100,000 colonies per ml urine from midstream clean catch or catheterization specimen)
10. Visible hematuria with subject urine sample without known contributing factor
11. Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function
12. Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms
13. Use of beta blockers, antihistamines, anticonvulsants, or antispasmodics within 1 week prior to treatment unless there is documented evidence of stable dosing for last 6 months (no dose changes)
14. Use of alpha blockers, antidepressants, anticholinergics, androgens, daily tadalafil or gonadotropin-releasing hormonal analogs (prescribed for BPH) within 3 weeks prior to treatment
15. Use of 5-alpha reductase inhibitor within 6 months prior to treatment
16. Incidence of spontaneous urinary retention within 6 months prior to baseline assessment
17. Post-void residual volume \> 250 ml or catheter dependent bladder drainage
18. Overactive bladder (OAB) or urge incontinence
19. Known poor detrusor muscle function (e.g. Qmax \< 5 ml/sec)
20. Current bladder stones or prostatic calculi
21. Biopsy of prostate within 30 days prior to procedure or planned within 30 days following the procedure
22. History of cancer in non-genitourinary system which is not considered cured (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered cured if there has been no evidence of cancer within five years
23. History of clinically significant comorbidities or presence of unstable conditions (e.g. cardiovascular, lung, renal \[serum creatinine \> 2.0 mg/dl\], hepatic, bleeding disorders, or metabolic impairment) that may confound the results of the study or have a risk to subject per investigator's opinion
24. Any cognitive disorder that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affects the ability to complete the study quality of life questionnaires
25. Expected life expectancy \< one year
26. Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the follow-up requirements
27. Currently enrolled in or plan to enroll in another investigational clinical trial for any disease except for observational only study
28. In the opinion of the investigator, it is not in the subject's best interest to participate in the study
29. Current treatment with anti-coagulants (e.g., warfarin or enoxaparin) or anti-platelet medications other than aspirin (e.g., clopidogrel)
30. Anatomy, e.g. presence of false passage or size of meatus, is not suitable for treatment in this study
31. Device that corresponds with the subject's prostate size per the IFU is not available
32. Intravesical prostatic protrusion (IPP) \> 1 cm
33. Current uncontrolled diabetes (hemoglobin A1c \> 7%)
34. Unable or unwilling to provide all the protocol-required semen samples
35. Sensitivity to paclitaxel, on medication that may have negative interaction with paclitaxel, or contraindicated for systemic paclitaxel <Conditions:>Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy <Interventions:>Optilume™ BPH Prostatic DCB Dilation Catheter, Paclitaxel | 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Prostate Volume (g)', 'Presence of Intravesical Prostatic Protrusion' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Post-bypass Prophylactic IVIG in Infants and Neonates <BriefSummary:>The purpose of this study protocol is to determine if administering Intravenous Immunoglobulin (IVIG) for treatment of cardiopulmonary bypass (CPB) induced hypogammaglobulinemia in the early post-operative period can impact post-surgical outcomes (i.e., infection, fluid overload, and associated morbidities). <EligibilityCriteria:>Inclusion Criteria:
* Infants \<6 months old
* Successfully weaned off cardiopulmonary bypass after cardiac surgery
Exclusion Criteria:
* Requirement of extra corporeal membrane oxygenation in the operating room
* Known immune deficiency
* Current Do Not Resuscitate or limitation of care order
* Current enrollment in another interventional clinical study
* Refusal of parental consent <Conditions:>Hypogammaglobulinemia, Congenital Heart Disease <Interventions:>IVIG, Placebo | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Weight', 'Gestational Age', 'STAT category', 'Cardiopulmonyar bypass time', 'Aortic cross clamp time', 'Intubated Pre-operatively' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Efficacy and Safety Study of Satralizumab (SA237) as Monotherapy to Treat Participants With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD) <BriefSummary:>The objectives of this study are to evaluate the efficacy, safety, pharmacodynamic, pharmacokinetic and immunogenic profiles of satralizumab in participants with NMO and NMOSD. <EligibilityCriteria:>Inclusion Criteria:
1. Participants must be diagnosed as having either neuromyelitis optica (NMO) or NMO spectrum disorder (NMOSD), defined as the following:
1. NMO as defined by Wingerchuk et al. 2006 criteria (requires all of the following 3 criteria: I. Optic neuritis, II. Acute myelitis, III. At least two of three supportive criteria: Contiguous spinal cord lesion identified on a magnetic resonance imaging \[MRI\] scan extending over 3 vertebral segments; Brain MRI not meeting diagnostic criteria for multiple sclerosis \[MS\]; NMO-IgG seropositive status)
2. NMOSD as defined by either of following criteria with anti-aquaporin-4 (AQP4) antibody seropositive status at screening: i. Idiopathic single or recurrent events of longitudinally extensive myelitis (≥3 vertebral segment spinal cord MRI lesion); ii. Optic neuritis, single, recurrent or simultaneous bilateral
2. Clinical evidence of at least 1 documented relapse (including first attack) in last 12 months prior to screening
3. Expanded Disability Status Scale (EDSS) score from 0 to 6.5 inclusive at screening
4. Age 18 to 74 years, inclusive at the time of informed consent
5. Ability and willingness to provide written informed consent and to comply with the requirements of the protocol
Exclusion Criteria:
1. Clinical relapse onset (including first attack) within 30 days prior to baseline
Exclusion Criteria Related to Previous or Concomitant Therapy:
2. Any previous treatment with interleukin 6 (IL-6) inhibitory therapy (e.g., tocilizumab), alemtuzumab, total body irradiation or bone marrow transplantation at any time
3. Any previous treatment with anti-CD20, eculizumab, anti-BLyS monoclonal antibody (e.g., belimumab), any other treatment for prevention of multiple sclerosis (MS) relapse (e.g., interferon, natalizumab, glatiramer acetate, fingolimod, teriflunomide or dimethyl fumarate) within 6 months prior to baseline
4. Any previous treatment with anti-CD4, cladribine, cyclophosphamide or mitoxantrone within 2 years prior to baseline
5. Treatment with any investigational agent within 3 months prior to baseline
Exclusions for General Safety:
6. Pregnancy or lactation.
7. For participants of reproductive potential, a positive result from a serum pregnancy test at screening, or not willing to use reliable means of contraception (physical barrier \[participants or partner\] in conjunction with a spermicidal product, contraceptive pill, patch, injectables, intrauterine device or intrauterine system) during the treatment period and for at least 3 months after the last dose of study drug
8. Any surgical procedure (except for minor surgeries) within 4 weeks prior to baseline
9. Evidence of other demyelinating disease or progressive multifocal leukoencephalopathy (PML)
10. Evidence of serious uncontrolled concomitant diseases that may preclude participant participation, as described; Other nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency
11. Known active infection (excluding fungal infections of nail beds or caries dentium) within 4 weeks prior to baseline
12. Evidence of chronic active hepatitis B or C
13. History of drug or alcohol abuse within 1 year prior to baseline
14. History of diverticulitis that, in the Investigator's opinion, may lead to increased risk of complications such as lower gastrointestinal perforation
15. Evidence of active tuberculosis (excluding participants receiving chemoprophylaxis for latent tuberculosis infection)
16. Evidence of active interstitial lung disease
17. Receipt of any live or live attenuated vaccine within 6 weeks prior to baseline
18. History of malignancy within the last 5 years, including solid tumors, hematologic malignancies and in situ carcinoma (except basal cell and squamous cell carcinomas of the skin, or in situ carcinoma of the cervix uteri that have been completely excised and cured)
19. History of severe allergic reaction to a biologic agent (e.g., shock, anaphylactic reactions)
20. Active suicidal ideation within 6 months prior to screening, or history of suicide attempt within 3 years prior to screening
21. History of Stevens-Johnson syndrome
22. Following laboratory abnormalities at screening\*.
1. White blood cells \<3.0 x10\^3/microliter (μL)
2. Absolute neutrophil count \<2.0 x 10\^3 /μL
3. Absolute lymphocyte count \<0.5 x 10\^3 /μL
4. Platelet count \<10 x 10\^4 /μL
5. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>1.5 times the upper limit of normal.
* If retest is conducted, the last value of retest before randomization must meet study criteria. <Conditions:>Neuromyelitis Optica (NMO), NMO Spectrum Disorder (NMOSD) <Interventions:>Satralizumab, Placebo | 'Age, Continuous', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Race/Ethnicity, Customized' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Reach for Health Study: Obesity-related Mechanisms and Mortality in Breast Cancer Survivors <BriefSummary:>This objective of this randomized controlled trial is to conduct a 2x2 test of a lifestyle intervention and metformin (a drug used to treat diabetes) to investigate how these treatments, alone or in combination, affect biomarkers associated with breast cancer survival. The Reach for Health Study will enroll 340 overweight/obese, postmenopausal breast cancer survivors. After completing the screening process and baseline measures, participants will be randomized in equal numbers to: (1) placebo, (2) metformin, (3) lifestyle intervention and placebo, or (4) lifestyle intervention and metformin. The intervention was powered on the main effects and the planned analyses are to compare: Metformin to Placebo and a separate comparison of Lifestyle intervention to control. The interventions will last for 6 months. Concentrations of circulating biomarkers will be assessed at baseline and 6 months. <EligibilityCriteria:>Inclusion Criteria:
* BMI at least 25.0 kg/m2
* Diagnosed with Stage I, II, or III breast cancer within past 5 years
* Treatment with total mastectomy or breast-sparing surgical removal of cancer with clear macroscopic margins, and axillary dissection, followed by adjuvant breast radiation
* Not scheduled for or currently undergoing chemotherapy
* Accessible geographically and by telephone
* Able to communicate dietary and physical activity data via telephone
* If taking statins, tamoxifen, or aromatase inhibitors; able and willing to remain on treatment for 6-month study period
* Post-menopausal at diagnosis
Exclusion Criteria:
* Preliminary bloodwork outside of specified ranges
* Evidence of renal insufficiency, liver disease, or congestive heart failure
* Currently taking corticosteroid pills or steroid hormone therapy (including vaginal estrogen creams)
* Recent initiation (\< 3 months ago) of thiazides or β-blockers
* Taking insulin or other antidiabetic drug
* Other primary or recurrent invasive cancer in past 10 years
* Unable to commit to study requirements <Conditions:>Breast Neoplasms <Interventions:>Metformin, Placebo, Lifestyle intervention, Standard printed dietary guidelines | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race/Ethnicity, Customized', 'Time Since Diagnosis', 'Body Mass Index' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Losartan in Treating Patients With Idiopathic Pulmonary Fibrosis <BriefSummary:>RATIONALE: Losartan may be effective in treating patients with idiopathic pulmonary fibrosis.
PURPOSE: This clinical trial is studying the side effects of losartan and to see how well it works in treating patients with idiopathic pulmonary fibrosis. <EligibilityCriteria:>INCLUSION CRITERIA:
* Age \> 21 years
* Diagnosis of idiopathic pulmonary fibrosis
* Patients taking Coumadin and/or N-acetylcysteine may participate in the study
* Baseline forced vital capacity (FVC) must be greater than or equal to 50%
* Baseline 6 minute walk test distance walked must be greater than or equal to 200 meters not requiring greater than 6 lpm of oxygen
EXCLUSION CRITERIA:
* Pregnant, intending to become pregnant or breastfeeding
* Current or previous smoker of cigarettes or marijuana that recently quit within the last 6 months prior to enrollment
* Allergy or allergic reaction to Losartan or any other angiotensin II receptor blocker
* Taking losartan or any other angiotensin II receptor blocker
* Baseline systolic blood pressure \< 100 mmHg
* Currently taking or has taken immunosuppressant agents within the last month such as azathioprine, cyclophosphamide, colchicine and/or prednisone
* History of lung transplant
* History of kidney failure or liver disease
* Inability to attend clinic visits <Conditions:>Precancerous Condition <Interventions:>losartan | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment', 'FVC% Predicted', 'DLCO% Predicted', '6MWT Distance', 'Chronic O2 Supplementation' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Transcranial Magnetic Stimulation for Attention Deficit/Hyperactivity Disorder (ADHD) <BriefSummary:>This study will test the effects of transcranial magnetic stimulation (TMS) on clinical measures of ADHD symptoms. <EligibilityCriteria:>Inclusion Criteria:
Eligible participants will be:
1. Healthy males and females who are between 18 and 65 years of age with an ADHD diagnosis (meet diagnostic criteria for ADHD on the SCID-5 module for adult ADHD).
2. Planning to live in the area for at least the next 6 weeks;
3. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined consent and HIPAA form;
4. Able to communicate fluently in English (speaking, writing, and reading).
Exclusion Criteria:
Subjects who present and/or self-report with the following criteria at any point during study participation will not be eligible to participate in the study:
Alcohol/Drugs:
1. History or current diagnosis or treatment for alcohol or drug abuse (as reported during phone screen);
2. Positive breath alcohol concentration test (BrAC greater than or equal to 0.01) at intake;
3. A positive urine drug screen for cocaine, phencyclidine (PCP), amphetamines, methamphetamines, benzodiazepines, methadone, and/or barbiturates at Intake, Baseline, or Sessions 5, 10, 15 or 20.
Medication:
Current use or recent discontinuation (within the past 6 months at the time of Intake) of:
1. Gamma-Aminobutyric Acid (GABA)-ergic medications
2. Glutamatergic medications
3. Any medication for the treatment of ADHD
4. Benzodiazepines
5. Any medication that is known to lower the seizure threshold (e.g.,clozapine, bupropion, tramadol, carbapenems, stimulants)
6. Any medication that could compromise participant safety as determined by the Principal Investigator and/or Study Physician
Current use or recent discontinuation (within the last 14 days at the time of Intake) of:
7. Anti-psychotic medications
8. Nicotine replacement therapy (NRT)
Daily use of:
9. Opiate-containing medications for chronic pain
Medical/Neuropsychiatric:
1. Women who are pregnant, planning a pregnancy, and/or breast feeding.
2. History of seizures, epilepsy, or history of epilepsy in first-degree relative
3. History of stroke or transient ischemic attack (warning stroke)
4. History of traumatic brain injury or self-report of brain or spinal tumor
5. History of head injury with unconsciousness lasting more than 5 minutes
6. Previous brain surgery
7. Any additional neurological condition that would likely reduce the safety of study participation, including central nervous system (CNS) vasculitis, intracranial tumor, intracranial aneurysm, multiple sclerosis or arteriovenous malformations
8. History of tinnitus
9. History of diabetes mellitus
10. History of atherosclerotic vascular disease
11. A medically unstable cardiopulmonary or metabolic disorder
12. Increased risk for myocardial infarction or other major cardiopulmonary complications.
13. Any uncorrected visual impairment or abnormality
14. Self-reported history, current diagnosis of psychosis or symptoms consistent with a mood disorder based upon the Structured Clinical Interview for DSM-5 (SCID); including schizophrenia, mania, bipolar disorder, an eating disorder, obsessive compulsive disorder, an anxiety disorder, major depression (subjects with a history of major depression but in remission for past 6 months are eligible).
TMS-related:
1. Subjects with ferromagnetic material in or in close proximity to the head (with the exception of oral dental devices)
2. Implanted devices (including vagus nerve stimulator (VNS), deep brain stimulator (DBS), pacemakers, spinal cord stimulators, medication pumps, ventriculo peritoneal shunts, defibrillators, intracardiac lines)
3. Self-report of any skull fracture or opening
4. A disturbance in normal sleep patterns/sleep deprivation
General Exclusion:
1. Any medical condition, illness, disorder, or concomitant medication that could compromise participant safety or treatment, or affect clinical or cognitive outcomes, as determined by the Principal Investigator
2. Inability to complete study tasks and provide quality data, as determined by the Principal Investigator
3. Low or borderline intellectual functioning - determined by a score of less than 90 on the Shipley Institute of Living Scale (SILS) (administered at Intake Visit). The SILS correlates with the Wechsler Adult Intelligence Scale-Revised (WAIS-R) Estimated Intelligence Quotient (IQ) Test
4. Inability to provide informed consent <Conditions:>Attention Deficit Disorder With Hyperactivity (ADHD) <Interventions:>Transcranial Magnetic Stimulation (TMS), Sham Transcranial Magnetic Stimulation (Sham TMS) | 'Age, Continuous', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Education', 'Smoking Status' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Trial of Oral Glutamine on Mitochondrial Function in CKD <BriefSummary:>The primary goal of proposed investigation is to study the impact of oral glutamine supplementation on muscle mitochondrial and endothelial cell function measured mitochondrial energetics and vascular function using 31P magnetic resonance spectroscopy and optical spectroscopy (MRS/OS) among persons with moderate-severe CKD. The secondary objective is to describe the impact of oral glutamine supplementation on mitochondrial metabolic profile as well as inflammatory and oxidative stress biomarkers among persons with chronic kidney disease. <EligibilityCriteria:>Inclusion Criteria:
* Adults between 20 and 69 years of age
* Diagnosis of moderate-severe CKD, defined in this study as an estimated glomerular filtration rate (eGFR) of ≤60ml/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration equation
* Ability to understand and provide informed consent to participate in the study
Exclusion Criteria:
* On chronic dialysis
* Expectation to start dialysis within 6 months or dialysis access in place.
* Pregnant
* Have physical immobility (defined by wheelchair use)
* Insulin dependent diabetes
* Have implants incompatible with MRI
* Exercise limiting cardiopulmonary disease (e.g. angina, severe heart valve disease, severe COPD, coronary ischemia)
* Use of anticoagulation (i.e. warfarin)
* Baseline systolic blood pressure \>160 or diastolic blood pressure \>100
* Inflammatory conditions (e.g. autoimmune disease, HIV)
* Thyroid disease
* Dementia or inability to consent
* Cirrhosis, active/chronic hepatitis
* Use medications interfering with muscle or mitochondrial function, including steroids, anti-psychotic, Coenzyme Q-10, immunosuppresssives, antivirals, and muscle relaxants
* Weight \>300 lbs
* Personal history or family history of deep vein thrombosis, pulmonary embolism
* Active malignancy
* Patients hospitalized within the past 60 days for any reason.
* Patients with a history of a major atherosclerotic event (defined as combined incidence of myocardial infarction, urgent target-vessel revascularization, coronary bypass surgery, and stroke) within 3 months <Conditions:>Cardiovascular Disease, Sarcopenia, Endothelial Dysfunction, Muscle Mitochondrial Function, Kidney Disease <Interventions:>First Intervention (14 days), Washout (3 weeks), Second Intervention (14 days) | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Immune Globulin Intravenous (IGIV) To Treat Relapsing, Remitting Multiple Sclerosis <BriefSummary:>The trial will study 2 doses of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the number of relapses that occur in a 1 year treatment period. <EligibilityCriteria:>Inclusion Criteria:
* Symptoms consistent with Multiple Sclerosis up to 5 years
* Diagnosis of multiple sclerosis according to McDonald criteria.
* Diagnosis of relapsing-remitting (RR) multiple sclerosis (MS) (Defined as periods of worsening of neurological function with full recovery or with sequelae and residual deficit upon recovery; periods between disease relapses characterized by lack of disease progression
* Kurtzke Extended Disability Status Scale (EDSS) \< 5.0
* At least 1 defined and documented relapse during the last year. Prior relapses where symptoms were due solely to a change in Bowel/Bladder Function or Cognitive Function will not be considered relapses as defined by this protocol and therefore not counted for inclusion into the study.
* Females or males; females of childbearing potential must use adequate contraception
* Clinically stable for at least 30 days prior to entry
* At least 9 hyperintense T2 lesions on MRI or 1 Gd-enhancing lesion according to McDonald/Barkhof dissemination-in-space criteria at entry
* Patients who have been informed about available treatments and decided, not to go on these treatments
* Written informed consent obtained prior to the initiation of any study related procedures
Exclusion Criteria:
* Females who are pregnant, breast feeding, or if, of childbearing potential, unwilling to practice adequate contraception throughout the study
* Prior therapy with azathioprine or any immunosuppressant agents within 6 months prior to study entry
* Prior steroid, methylprednisolone or adrenocorticotropic hormone (ACTH) therapy within 30 days prior to study entry
* Therapy with interferons (Betaseron®, Avonex®, Rebif®), glatiramer acetate (Copaxone®) or IGIV within 3 months prior to study entry or during the study
* Use of an investigational compound within 6 months prior to study entry
* Previous lymphoid irradiation or prior to treatment with cyclophosphamide, methotrexate or mitoxantrone
* Cardiac insufficiency (NYHA III/IV), cardiomyopathy, significant cardiac dysrhythmia requiring treatment, unstable or advanced ischemic heart disease (CCS III or IV), or malignant hypertension
* History of renal insufficiency or serum creatinine levels greater than 2.5 mg/dL (221 µmol/L)
* Known selective immunoglobulin A (IgA) deficiency or known antibodies to IgA
* Conditions whose symptoms and effects could alter protein catabolism and/or immunoglobulin G (IgG) utilization (e.g., protein-losing enteropathies, nephrotic syndrome)
* Any medical, psychiatric or other circumstances which impede or restrict the patient's participation in the study or any contraindication to contrast enhanced MRI (e.g.,pacemaker, aortic clip or any metal implant)
* Patients with clinically significant medical conditions including, but not limited to cardiac, pulmonary, hepatic, hematological (e.g. known coagulation disorder, history of deep venous thrombosis and/or pulmonary embolism), endocrine,or renal dysfunction, autoimmune disorders, severe environmental allergies or chronic infections <Conditions:>Multiple Sclerosis, Relapsing-Remitting <Interventions:>Immune Globulin IV [Human], 10% Caprylate/Chromatography Purified, Albumin (Human) 25%, United States Pharmacopeia (USP) | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Study Utilizing BIOZEK COVID-19 Antigen Rapid Test <BriefSummary:>This is a research study to evaluate the Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test (Saliva) and BIOZEK COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) on samples that are self-collected; and to perform analysis to compare results. In addition, to obtain RT-PCR test results, performed prior to enrollment, and compare all three results. <EligibilityCriteria:>Inclusion Criteria:
* Subjects must be ≥18 years of age and have had an RT-PCR test performed prior to enrollment.
* Subjects must be able to understand and willingly sign a written informed consent. Additionally, participants need to meet at least 1 of the criteria listed below:
* Currently experiencing symptoms of COVID-19.
* Be clinically diagnosed or suspected to have COVID-19.
* Recent past (3 weeks) exhibited symptoms of COVID-19.
* Be capable of performing a self-collection of a nasopharyngeal sample with use of nasal swab kit.
* Be capable of performing a self-collection of an oral fluid sample with use of oral fluid collection kit.
* Interacted with a COVID-19 positive individual.
Exclusion Criteria:
Subjects who meet any of the following exclusion criteria may not be enrolled in this study:
* Cannot perform self-collection of a nasopharyngeal sample with use of nasal swab kit.
* Cannot perform self-collection of an oral fluid sample with use of oral fluid collection kit.
* Have a deviated nasal septum.
* Cognitively impaired individuals resulting in the inability to provide informed consent <Conditions:>Covid-19 Testing <Interventions:>Biozek Covid-19 Antigen Rapid Test (Saliva) | 'Age, Customized', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>A Four-Week Multicenter Study Evaluating the Safety and Efficacy of Gefapixant (AF-219/MK-7264) in Subjects With Osteoarthritis of the Knee <BriefSummary:>The purpose of this study is to assess the efficacy of a single dose level of gefapixant (AF-219/MK-7264) in subjects with moderate to severe pain associated with osteoarthritis (OA) of the knee compared with placebo after 4 weeks of treatment.
The study will also assess the safety and tolerability, changes in physical function, stiffness, treatment response and health outcomes. <EligibilityCriteria:>Inclusion Criteria:
* Men or women
* Women of child bearing potential must not be pregnant during the study and must use two forms of birth control
* Men and their female partners must use two forms of birth control
* Clinical and radiographic evidence of chronic knee osteoarthritis
* An average NPRS score of \>=5 and \<=9 over a 4-7 day washout period of their previous osteoarthritis medications
* Ambulatory
* Have provided written informed consent <Conditions:>Osteoarthritis of the Knee <Interventions:>Gefapixant, Sugar Pill | 'Age, Categorical', 'Sex: Female, Male', 'Race (NIH/OMB)', 'Region of Enrollment', 'Numeric Pain Rating Scale (NPRS)' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Stent vs. Indomethacin for Preventing Post-ERCP Pancreatitis <BriefSummary:>Background: Pancreatitis is the most frequent complication of endoscopic retrograde cholangiopancreatography (ERCP), accounting for substantial morbidity, occasional mortality, and increased health care expenditures. Until recently, the only effective method of preventing post-ERCP pancreatitis (PEP) had been prophylactic pancreatic stent placement (PSP), an intervention that is costly, time consuming, technically challenging, and potentially dangerous. The investigators recently reported the results of a large randomized controlled trial demonstrating that rectal indomethacin, a non-steroidal anti-inflammatory drug, reduced the risk of pancreatitis after ERCP in high-risk patients, most of whom (\>80%) had received a pancreatic stent. Secondary analysis of this RCT suggested that subjects who received indomethacin alone were less likely to develop PEP than those who received a pancreatic stent alone or the combination of indomethacin and stent, even after adjusting for underlying differences in subject risk. If indomethacin were to obviate the need for PSP, major clinical and cost benefits in ERCP practice could be realized.
Objective: To assess whether rectal indomethacin alone is non-inferior to the combination of rectal indomethacin and prophylactic pancreatic stent placement for preventing post-ERCP pancreatitis in high-risk cases.
Methods: Comparative effectiveness multi-center non-inferiority trial of rectal indomethacin alone vs. the combination of rectal indomethacin and prophylactic pancreatic stent placement for the prevention of post-ERCP pancreatitis in high-risk patients. One thousand four hundred and thirty subjects at elevated risk for PEP who would normally receive a pancreatic stent for prophylaxis will be randomized to indomethacin alone or the combination of indomethacin and PSP. The proportion of patients developing PEP and moderate-severe PEP will be compared. In addition, the investigators will establish a quality-assured central repository of biological specimens obtained from study participants, permitting future translational research elucidating the molecular and genetic mechanisms of PEP, as well as the mechanisms by which non-steroidal anti-inflammatory drugs prevent this complication. <EligibilityCriteria:>Inclusion Criteria:
Any patient undergoing ERCP in whom pancreatic stent placement is planned for post-ERCP pancreatitis prevention, is ≥ 18 years old, who provides informed consent, AND:
Has one of the following:
1. Clinical suspicion of or known sphincter of Oddi dysfunction
2. History of post-ERCP pancreatitis (at least one prior episode of pancreatitis after ERCP)
3. Pancreatic sphincterotomy
4. Pre-cut (access) sphincterotomy (freehand pre-cut and septotomy)
5. Difficult cannulation: cannulation duration ≥ 6 minutes (starting at time of initial papillary engagement with at least 25% of the time in contact with the papilla) AND/OR ≥ 6 cannulation attempts (defined as sustained contact with papilla lasting at least 1 second).
6. Short-duration (≤ 1 min) balloon dilation of an intact biliary sphincter.
Or has at least 2 of the following:
7. Age \< 50 years old \& female gender
8. History of recurrent pancreatitis (at least 2 episodes)
9. ≥3 pancreatic injections
10. Pancreatic acinarization
11. Pancreatic brush cytology
Exclusion Criteria:
1. Ampullectomy
2. Cases in which a pancreatic stent must be placed for therapeutic intent
3. Unwillingness or inability to consent for the study
4. Pregnancy
5. Breast feeding mother
6. Standard contraindications to ERCP
7. Allergy to Aspirin or NSAIDs
8. Known renal failure (Cr \> 1.4 mg/dl)
9. Ongoing or recent (within 2 weeks) hospitalization for gastrointestinal hemorrhage
10. Ongoing or recent (within 1 week) hospitalization for acute pancreatitis
11. Known chronic calcific pancreatitis
12. Pancreatic head malignancy
13. Procedure performed on major papilla/ventral pancreatic duct in patient with pancreas divisum (no manipulation of minor papilla)
14. ERCP for biliary stent removal or exchange without anticipated pancreatogram
15. Subjects with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram
16. Anticipated inability to follow protocol
17. Absence of rectum <Conditions:>Post-ERCP Pancreatitis <Interventions:>Indomethacin 100 mg rectally immediately after ERCP, NO prophylactic pancreatic stent placement, Indomethacin 100 mg rectally immediately after ERCP AND prophylactic pancreatic stent placement | 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race (NIH/OMB)', 'BMI', 'Antibiotic use in past 3 months', 'Clinical suspicion or known sphincter of Oddi dysfunction', 'History of post-ERCP pancreatitis', 'History of recurrent pancreatitis', 'Difficult cannulation', 'Precut (access) sphincterotomy', 'Number of pancreatic injections', 'Pancreatic sphincterotomy', 'Pancreatic acinarisation', 'Biliary sphincterotomy', 'Trainee involvement', 'Total intravenous fluid received during periprocedural period, mL', 'Total intravenous lactated Ringer's fluid received during periprocedural period, mL', 'Prophylactic pancreatic stent calibre in those who received a stent', 'Prophylactic pancreatic stent length in those who received a stent' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Clinical Trial of Low Dose Oral Interferon Alpha in Idiopathic Pulmonary Fibrosis <BriefSummary:>The purpose of this study is to determine the possible efficacy of low dose, orally administered interferon alpha in subjects with Idiopathic Pulmonary Fibrosis (IPF). <EligibilityCriteria:>Inclusion Criteria:
* The only subjects to be included in this study are those diagnosed with Idiopathic Pulmonary Fibrosis with diagnosis based on the criteria published by the American Thoracic Society in the International Consensus Statement.
1. Exclusion of other known causes of interstitial lung disease.
2. Abnormal pulmonary function studies.
3. Bibasilar reticular abnormalities with minimal ground glass opacities on HRCT scan.
4. Biopsy or lavage showing no features supporting alternative diagnosis.
5. Patient older than 50 years of age.
6. Insidious onset of otherwise unexplained dyspnea on exertion.
7. Duration greater than 3 months.
8. Bibasilar, inspiratory crackles.
Exclusion Criteria:
* under the age of 50
* history of hypersensitivity to interferons
* history of hypersensitivity to biological products such as vaccines
* pregnant or lactating women
* women of child bearing age not pregnancy protected during the study
* unresolved serious cardiovascular disease <Conditions:>Respiratory Tract Diseases, Lung Diseases, Lung Diseases, Interstitial, Pulmonary Fibrosis <Interventions:>Interferon alpha oral lozenge | 'Age, Categorical', 'Age Continuous', 'Sex: Female, Male', 'Region of Enrollment' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Study Investigating the Effect of 4 Doses of RPL554 Given in Addition to Tiotropium to Patients With COPD <BriefSummary:>The purpose of this study is to investigate the dose response of RPL554 in patients with moderate to severe CHRONIC OBSTRUCTIVE PULMONARY DISEASE that are still symptomatic despite treatment with a stable background of tiotropium over 4 weeks of treatment. This study is intended to support optimal dose selection for a Phase III program evaluating RPL554 as an add-on treatment to standard of care therapy. <EligibilityCriteria:>Inclusion Criteria:
* Sign an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study.
* Male or female aged between 40 and 80 years inclusive, at the time of informed consent.
* Must agree to meet the following from the first dose up to 1 month after the last dose of study medication:
* If male:
* Not donate sperm
* Either: be sexually abstinent in accordance with a patient's usual and preferred lifestyle (but agree to abide by the contraception requirements below should their circumstances change)
* Or: use a condom with all sexual partners. If the partner is of childbearing potential the condom must be used with spermicide and a second reliable form of contraception must also be used (e.g., diaphragm/cap with spermicide, established hormonal contraception, intra-uterine device)
* If female:
* be of non-childbearing potential or use a highly effective form of contraception
* Have a 12-lead ECG recording at Screening showing the following (and no changes in the pre-dose value at the first treatment deemed clinically significant by the Investigator):
* Heart rate between 45 and 90 beats per minute
* QT interval corrected for heart rate using Fridericia's formula (QTcF) ≤450 msec for males, and ≤ 470 msec for females
* QRS interval ≤ 120 msec
* No clinically significant abnormality including morphology (e.g., left bundle branch block, atrio-ventricular nodal dysfunction, ST segment abnormalities consistent with ischemia)
* Capable of complying with study restrictions and procedures, including ability to use the nebulizer correctly.
* Body mass index (BMI) between 18 and 35 kg/m2 (inclusive) with a minimum weight of 45 kg.
* COPD diagnosis: Patients with a diagnosis of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines (Celli and MacNee, 2004) with symptoms compatible with COPD for at least 1 year prior to Screening.
* Ability to perform acceptable and reproducible spirometry.
* Post-bronchodilator (four puffs of albuterol) spirometry at Screening demonstrating the following:
* FEV1/ FVC ratio of ≤0.70
* FEV1 ≥30% and ≤70% of predicted normal\* \*National Health and Nutrition Examination Survey (NHANES) III (Hankinson et al, 1999) will be used as the reference for normal predicted values.
* Clinically stable COPD in the 4 weeks prior to Screening (Visit 1) and during the period between Visits 1 and 2.
* A score of ≥2 on the modified Medical Research Council (mMRC) dyspnea scale at Screening.
* A chest X-ray (posterior-anterior) at Screening, or in the 12 months prior to Screening showing no clinically significant abnormalities unrelated to COPD.
* Meet the concomitant medication restrictions and be expected to do so for the rest of the study.
* Current and former smokers with smoking history of ≥10 pack years.
* Capable of withdrawing from long acting bronchodilators (other than tiotropium) for the duration of the study, and short acting bronchodilators for 6 hours prior to dosing.
Exclusion Criteria:
* A history of life-threatening COPD including Intensive Care Unit admission and/or requiring intubation.
* COPD exacerbation requiring oral or parenteral steroids, or lower respiratory tract infection requiring antibiotics, within 3 months of Screening or prior to the first treatment.
* A history of one or more hospitalizations for COPD or pneumonia within 6 months of Screening or prior to the first treatment.
* Intolerance or hypersensitivity to albuterol, tiotropium or other muscarinic receptor antagonists.
* Other respiratory disorders: Patients with a current diagnosis of asthma, active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases, uncontrolled or unstable sleep apnea, known alpha-1 antitrypsin deficiency, core pulmonale, clinically significant pulmonary hypertension or other active pulmonary diseases.
* Previous lung resection or lung reduction surgery.
* Pulmonary rehabilitation, unless such treatment has been stable from 4 weeks prior to Screening and remains stable during the study.
* Oral therapies for COPD (e.g. oral steroids, theophylline, and roflumilast) or antibiotics within 3 months prior to Screening, or ICS therapy within 4 weeks prior to Screening
* Prior exposure to RPL554.
* History of, or reason to believe a patient has, drug or alcohol abuse within the past 5 years.
* Received an experimental drug within 30 days or five half-lives, whichever is longer.
* Women who are pregnant or breast-feeding.
* Patients with uncontrolled disease including, but not limited to, endocrine, active hyperthyroidism, neurological, hepatic, gastrointestinal, renal, hematological, urological, immunological, psychiatric, or ophthalmic diseases that the Investigator believes are clinically significant. This includes any hepatic disease or moderate to severe renal impairment.
* Documented clinically significant cardiovascular disease such as: any history of arrhythmias, angina, recent (\<1 year) or suspected myocardial infarction, congestive heart failure, unstable or uncontrolled hypertension, or diagnosis of hypertension within 3 months prior to Screening.
* Use of non-selective oral β-blockers.
* Major surgery (requiring general anesthesia) within 6 weeks prior to Screening, lack of full recovery from surgery at Screening, or planned surgery through the end of the study.
* Required use of oxygen therapy, even on an occasional basis.
* History of malignancy of any organ system within 5 years, with the exception of localized skin cancers (basal or squamous cell).
* Clinically significant abnormal values for laboratory safety tests (hematology, blood chemistry, viral serology or urinalysis) at Screening, as determined by the Investigator. In particular, alanine aminotransferase or aspartate aminotransferase cannot be more than twice the upper limit of normal.
* Patients with conditions which are sensitive to antimuscarinic effects such as narrow angle glaucoma, urinary retention, prostatic hypertrophy, or bladder neck obstruction.
* Current marijuana use (all forms).
* A disclosed history or one known to the Investigator, of significant non-compliance in previous investigational studies or with prescribed medications.
* Any other reason that the Investigator considers makes the patient unsuitable to participate. <Conditions:>COPD <Interventions:>Ensifentrine (formerly RPL554) 0.375 mg twice daily plus placebo, in addition to tiotropium, Ensifentrine (formerly RPL554) 0.75 mg twice daily plus placebo, in addition to tiotropium, Ensifentrine (formerly RPL554) 1.5 mg twice daily plus placebo, in addition to tiotropium, Ensifentrine (formerly RPL554) 3.0 mg twice daily plus placebo, in addition to tiotropium, Ensifentrine (formerly RPL554) placebo twice daily, in addition to tiotropium | 'Age, Categorical', 'Age, Continuous', 'Sex: Female, Male', 'Ethnicity (NIH/OMB)', 'Race/Ethnicity, Customized' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection <BriefSummary:>This 2 arm study will evaluate the efficacy, safety and tolerability of saquinavir/ritonavir or lopinavir/ritonavir in combination with emtricitabine/tenofovir in patients with human immunodeficiency virus type 1 (HIV-1) infection who have received no prior HIV treatment. Patients will be randomized to receive either saquinavir/ritonavir 1000/100mg oral (po) twice daily (bid) + emtricitabine/tenofovir 200/300mg po once daily (qd), or lopinavir/ritonavir 400/100mg po bid + emtricitabine/tenofovir 200/300mg po qd. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. <EligibilityCriteria:>Inclusion Criteria:
* adult patients \>=18 years of age;
* chronic HIV-1 infection;
* treatment-naive;
* HIV-1 RNA viral load \>=10,000copies/mL;
* women of childbearing potential must have a negative pregnancy test, and must use reliable contraception for the duration of the study and for 90 days after the last dose of study medication.
Exclusion Criteria:
* females who are pregnant or breastfeeding;
* active hepatitis B infection;
* previous treatment with antiretroviral medication;
* patients who have received an investigational drug within the last 4 weeks. <Conditions:>HIV Infections <Interventions:>saquinavir [Invirase], Lopinavir/ritonavir, Emtricitabine/tenofovir disoproxil fumarate, Ritonavir | 'Age Continuous', 'Sex: Female, Male' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Clinical Study With Blinatumomab in Patients With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) <BriefSummary:>The purpose of this study is to confirm whether the bispecific T cell engager antibody blinatumomab (MT103) is effective and safe in the treatment of patients with relapsed or refractory Acute Lymphoblastic Leukemia (ALL). <EligibilityCriteria:>Inclusion Criteria:
* Patients with Philadelphia chromosome (Ph)-negative B-precursor ALL, with any of the following:
* relapsed or refractory with first remission duration less than or equal to 12 months in first salvage or
* relapsed or refractory after first salvage therapy or
* relapsed or refractory within 12 months of allogeneic hematopoietic stem cell transplantation (HSCT)
* 10% or more blasts in bone marrow
* In case of clinical signs of additional extramedullary disease: measurable disease
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Age ≥ 18 years
Exclusion Criteria:
* Patients with Ph-positive ALL
* Patients with Burkitt's Leukemia according to World Health organization (WHO) classification
* History or presence of clinically relevant central nervous system (CNS) pathology
* Active ALL in the CNS or testes
* Current autoimmune disease or history of autoimmune disease with potential CNS involvement
* Autologous HSCT within six weeks prior to start of blinatumomab treatment
* Allogeneic HSCT within three months prior to start of blinatumomab treatment
* Any active acute graft versus-host disease (GvHD), or active chronic GvHD Grade 2 - 4
* Any systemic therapy against GvHD within two weeks prior to start of blinatumomab treatment
* Cancer chemotherapy within two weeks prior to start of blinatumomab treatment
* Radiotherapy within two weeks prior to start of blinatumomab treatment
* Immunotherapy (e.g., rituximab) within four weeks prior to start of blinatumomab treat-ment
* Any investigational anti-leukemic product within four weeks prior to start of blinatumomab treatment
* Treatment with any other investigational medicinal product (IMP) after signature of informed consent
* Eligibility for allogeneic HSCT at the time of enrollment
* Known hypersensitivity to immunoglobulins or to any other component of the IMP formulation
* Abnormal laboratory values indicative of inadequate renal or liver function
* History of malignancy requiring treatment other than ALL within five years prior to start of blinatumomab treatment with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix
* Any concurrent disease or medical condition that is deemed to interfere with the conduct of the study
* Infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus or hepatitis C virus
* Pregnant or nursing women
* Women of childbearing potential not willing to use an effective form of contraception. Male patients not willing to ensure not to beget a child
* Previous treatment with blinatumomab <Conditions:>Acute Lymphoblastic Leukemia <Interventions:>Blinatumomab | 'Age, Continuous', 'Age, Customized', 'Sex: Female, Male', 'Race/Ethnicity, Customized', 'Disease stage entry criteria met', 'Number of prior relapses', 'Prior allogeneic HSCT and prior relapses', 'Number of prior salvage therapies', 'Time since initial diagnosis', 'Time since last relapse', 'Baseline bone marrow blast category' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>Investigation of AVACEN Thermal Exchange System for Fibromyalgia Pain <BriefSummary:>Hypothesis: Daily use of the AVACEN Thermal Exchange System for 4 weeks will show improved Fibromyalgia pain and functioning markers, as assessed by biomarkers and clinical and psychological assessment. This non-invasive device is able to rapidly raise the core body temperature of the user by placing a hand in a vacuum chamber and resting it upon a heating element. The change in body temperature may change the sympathetic nervous system's activity and thereby reduce Fibromyalgia pain. <EligibilityCriteria:>Inclusion Criteria:
* Fibromyalgia diagnosis
* Over the age of 18
* Understands English
* Not pregnant/planning to become pregnant
* Average pain of 4 or greater over the last week (10 point scale)
* Fibromyalgia pain lasting longer than 6 months
Exclusion Criteria:
* Pregnant/Planning to become pregnant
* Major unstable psychiatric illness
* Major, uncontrolled systemic illness for which you may be hospitalized in the next 6 months <Conditions:>Fibromyalgia <Interventions:>AVACEN Thermal Exchange System | 'Age, Customized', 'Gender', 'Region of Enrollment', 'Widespread Pain Index (WPI)', 'Tender Point Count (TPC)', 'Symptom Severity (SS) Score' |
You're a helpful assistant and a clinical trial expert. For each query trial, produce a list of probable baseline features (each in backticks and comma-separated). Baseline features are demographic characteristics used in primary outcome analysis, often shown by groups in clinical publications. Only return the list, no additional explanations necessary. Example format: 'feature 1', 'feature 2'. | <Title:>AZD2423 Safety and Tolerability Study in Patients With Moderate and Severe Chronic Obstructive Pulmonary Disease(COPD) <BriefSummary:>The purpose of the study is to investigate the tolerability and safety of AZD2423 in Patients with chronic obstructive pulmonary disease. <EligibilityCriteria:>Inclusion Criteria:
* Male or female of non-child bearing potential. Only women of non-child bearing potential are included in the study i.e. women who are permanently or surgically sterilised or post menopausal.
* Between 40 and 80 years of age at Visit 1
* Clinical diagnosis of COPD (GOLD stage 2 or 3)
* FEV1/FVC \<70% and FEV1 between 30 and 80% of the predicted normal post-bronchodilator (GOLD stage 2 or 3)
* Current or ex-smokers
Exclusion Criteria:
* Any clinically significant disease or disorder (including history of abnormal immune function) which, in the opinion of the Investigator, may either put the subject at risk or influence the way the drug works
* Any lung disease other than COPD, recent respiratory infections which have not resolved fully, active tuberculosis or at risk of reactivation of tuberculosis.
* Any abnormal findings in physical examination, blood or urine test results, vital signs or ECG at Visit 1 that may put the subject at risk during the study, affect their ability to take part or influence the results of the study
* Immunisation with a live vaccine within 3 months or other vaccination within 30 days before planned start of treatment
* Worsening of COPD symptoms within 4 weeks prior to start of study needing hospitalisation, oral steroids or antibiotics. <Conditions:>Chronic Obstructive Pulmonary Disease, Lung Disease <Interventions:>AZD2423, Placebo to AZD2423 | 'Age, Continuous', 'Sex: Female, Male' |