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<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - TREAT (Severe Alcoholic Hepatitis)[/INST] Hypothesis: Oral administration of hyperimmune bovine colostrum enriched with anti-LPS antibodies will reduce endotoxemia, and improve pathophysiological and clinical parameters related to severe alcoholic hepatitis (SAH). IMM 124-E is safe in subjects with severe alcoholic hepatitis being treated with steroids. Aim: To perform a phase 2a "proof of concept" placebo-controlled, dose-ranging study of Imm 124-E (hyperimmune bovine colostrum enriched with IgG anti-LPS) in subjects with severe AH on steroids. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - EVOLVE-MS-2 (vs. Tecfidera)[/INST] The objectives of this study are to evaluate the utility of two gastrointestinal (GI) symptom scales (Individual GI Symptom and Impact Scale {IGISIS} and Global GI Symptom and Impact Scale {GGISIS}) in assessing GI tolerability in adult subjects with RRMS after administration of ALKS 8700 or Dimethyl Fumarate (DMF) in Part A, to compare the GI tolerability of ALKS 8700 and DMF in adult subjects with RRMS using IGISIS and GGISIS in Part B, and to Evaluate the safety and tolerability of ALKS 8700 in adult subjects with RRMS in Parts A and B. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> Phase 1, double-blind, placebo-controlled, dose escalation study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single intravenous administrations of GGF2 in cohorts of patients with left ventricular dysfunction and symptomatic heart failure. [/INST] Study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single intravenous administrations of GGF2 in patients with heart failure. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> PRIMARY OBJECTIVES: - I. To estimate the maximum tolerated dose (MTD) and examine the dose-limiting toxicities of nintedanib when administered with capecitabine within the study population and, establish the recommended phase II dose (RP2D). (Phase I) - II. To assess progression free survival at 18 weeks. (Phase II) SECONDARY OBJECTIVES: - I. To assess median progression free survival. (Phase II) - II. To assess median overall survival from the date of enrollment to the time of death will be documented. (Phase II) - III. To assess the objective response rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. (Phase II) - IV. To assess the toxicity of dose regimen using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.0). (Phase II) TERTIARY OBJECTIVES: - I. Measurement of circulating angiogenic cytokines (CAFs): vascular endothelial growth factor (VEGF), soluble vascular endothelial growth factor receptor (sVEGFR) 1/2, placental growth factor (PlGF), granulocyte macrophage colony-stimulating factor (GMCSF), leptin, interleukin (IL)-1 alpha (a), IL-8, IL-6, fibroblast growth factor basic (FGFb), osteopontin and pentraxin-3. (Phase II) - II. Measurement of drug levels and pharmacokinetic (PK)/pharmacodynamic (PD) modeling. (Phase II) OUTLINE: This is a phase I, dose-escalation study of nintedanib followed by a phase II study. Patients receive capecitabine orally (PO) twice daily (BID) (every 12 hours) on days 1-14 and nintedanib PO BID (every 12 hours) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days, every 28 days until resolution or satisfactory stabilization of persistent drug-related toxicity, and then every 6 months thereafter. [/INST] This phase I/II trial studies the side effects and best dose of nintedanib when given together with capecitabine and to see how well they work in treating patients with colorectal cancer that has not responded to previous treatment (refractory) and has spread to other places in the body (metastatic). Nintedanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also block the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nintedanib with capecitabine may be a better treatment for colorectal cancer. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - Advanced Cancer[/INST] Part A- The purpose of this study is to determine a safe dose of LY2801653 to be given to participants with advanced cancer and to determine any side effects that may be associated with LY2801653 in this participant population. Efficacy measures will be used to assess the activity of LY2801653. Part B- The dose determined in Part A will be used along with efficacy measures to assess the activity of LY2801653 in participants with adenocarcinoma of the colon or rectum, head and neck squamous cell carcinoma (HNSCC), uveal melanoma with liver metastasis, and cholangiocarcinoma. Part C - the objective of Part C is to determine a recommended Phase 2 dose of LY2801653 that may be safely given to participants with HNSCC when taken with standard doses of cetuximab Part D - the objective of Part D is to determine a recommended Phase 2 dose of LY2801653 that may be safely given to participants with cholangiocarcinoma when taken with a standard dose of cisplatin. Part E - the objective of Part E is to determine a recommended Phase 2 dose of LY2801653 that may be safely given to participants with cholangiocarcinoma when taken with gemcitabine plus cisplatin. Part F - the objective of Part F is to determine a recommended Phase 2 dose of LY2801653 that may be safely given to participants with gastric cancer when taken with ramucirumab. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This is a randomized, double-blind, placebo-controlled, single center study in subjects who have undergone third molar extraction surgery. Eligible subjects will have surgical removal of >2 third molars, of which at least 1 must be a complete or partial mandibular impaction. Each subject's study participation will consist of a screening visit (1-21 days prior to surgery), an inpatient evaluation period of 24 hours following dosing, and a follow-up phone call 3-5 days postdose. [/INST] To evaluate the safety and efficacy of single IV doses of N1539 after dental impaction surgery. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This study is a randomized, double-blinded, efficacy trial of the effects of udenafil vs. placebo on the background of standard therapy on maximal VO2 (ml/kg/min) from baseline to six months in adolescent survivors of the Fontan procedure. . The target sample size is 400 subjects (200 per group). [/INST] This study will evaluate the clinical efficacy and safety of udenafil, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of adolescent subjects who have undergone the Fontan procedure. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This is a Phase 3, randomized, double-blind, placebo-controlled, in-patient, efficacy, and safety study to evaluate HP-3070 for the treatment of schizophrenia. This study is designed to evaluate efficacy and safety of HP-3070 compared with placebo transdermal patch in subjects diagnosed with schizophrenia, who are in an acute exacerbation and to assess the impacts of covariates on asenapine exposure as delivered in a patch formulation, using a population-based approach. [/INST] This study is designed to evaluate efficacy and safety of HP-3070 compared with placebo transdermal patch in subjects diagnosed with schizophrenia. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - HypoPal[/INST] A randomized, double-blind, parallel-group trial to confirm the clinical efficacy and safety of dasiglucagon in the rescue treatment of hypoglycemia in subjects with type 1 diabetes mellitus (T1DM) compared to placebo </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This is a Phase I, open-label, dose-escalation study to characterize the safety, tolerability, pharmacokinetic profile, pharmacodynamic profile, and clinical activity of the oral PI3K inhibitor GSK2126458 and the oral MEK inhibitor GSK1120212 dosed in combination in subjects with advanced solid tumors. The study will be conducted in 2 parts, a Part 1 dose escalation phase and a Part 2 tumor specific cohort expansion. A continuous daily dosing schedule will be utilized initially for both investigational products. The frequency and schedule of dosing may be adjusted based on emerging safety, pharmacokinetics, and pharmacodynamics data. Once a recommended regimen has been characterized in Part 1, it may be further evaluated in Part 2 . More than one regimen (doses and schedules) may be evaluated in Part 2, based on findings in Part 1. Subjects eligible for enrollment in Part 2 will have solid tumors with genetic profiles that are likely to benefit from a MEK and PI3K pathway inhibition. [/INST] This is a Phase I, open-label, dose-escalation study to characterize the safety, tolerability, pharmacokinetic profile, pharmacodynamic profile, and clinical activity of the oral PI3K inhibitor GSK2126458 and the oral MEK inhibitor GSK1120212 dosed in combination in subjects with advanced solid tumors. The study will be conducted in 2 parts, a dose escalation phase and a tumor specific cohort expansion. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This study planned to assess long-term safety and tolerability of QGE031 administered every 4 weeks for an additional 12 months in patients with allergic asthma who previously completed study CQGE031B2201. The study was terminated early due to the efficacy results from an interim analysis of the Phase II study CQGE031B2201. [/INST] This study planned to assess long-term safety of QGE031 during 12 months treatment in asthma patients who completed study CQGE031B2201. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - Healthy Adult Volunteers[/INST] This is a first in human study to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of ONO-5788 in healthy adult volunteers. This study will be conducted in 4 parts: a single-ascending dose part, a multiple-ascending dose part, an elderly part and a proof of principle part. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> AV0328 is a novel vaccine candidate intended to raise antibodies to the glucosamine backbone of naturally occurring Poly N-acetyl glucosamine (PNAG), a capsular polysaccharide expressed on the surface of a wide array of microbes. AV-101-16: A single and repeat dose, dose-escalation phase I/II study to evaluate the safety of intramuscularly administered AV0328. Approximately 16 subjects will be enrolled at a single U.S. center, based on 4 subjects per dose group. The study will consist of 3 parts: Part 1 will be a single dose, dose escalation study; Part 2 will assess the effect of a second dose of AV0328; Part 3 will assess the ability of a booster injection of AV0328 at Month 6 to restore protective titers against N. meningitidis B16B6 bacteria. Part 1 - Single Administration of AV0328: Following injection, subjects will be observed for 28 days to determine the safety and tolerability of a single administration of AV0328. Cohort 1 will receive 15 µg to be given as an IM injection on Day 1. Cohorts 2, 3 and 4 will receive 30, 75 and 150 µg, respectively. The first subject of each cohort must be observed for a minimum of 24 hours before the remaining subjects in that group can be treated. Dosage escalation will occur only after the final subject at each dose level has been observed for a minimum of 2 days and no dose limiting drug-related toxicity has occurred. Part 2 - Second Administration of AV0328: Following review of safety and tolerance for a minimum of 22 days of Part 1 by the Safety Review Committee (SRC), subjects from each dose level will return to receive an additional injection at the same dose level of AV0328 on Day 29. Additional safety and pharmacodynamic (PD) data will be collected through Week 52. Part 3 - Booster Administration of AV0328 Serum drawn at Day 57 revealed that 3 of 4 subjects in Cohort 3 and all 4 subjects in Cohort 4 achieved protective titers against N. meningitidis B16B6 bacteria, defined as >30% killing at a titer of 1:8 or greater by BSA. If those titers fall below protective levels in a subject at 4 or 6 months, that subject will receive a booster injection at the 6-month time point or shortly thereafter. The dose will be 150 µg, IM which will be formulated in the same manner as the 150 µg dose in Parts 1 and 2. [/INST] AV0328 is a novel vaccine candidate intended to raise antibodies to the glucosamine backbone of naturally occurring Poly N-acetyl glucosamine (PNAG), a capsular polysaccharide expressed on the surface of a wide array of microbes. AV-101-16: A single and repeat dose, dose-escalation phase I/II study to evaluate the safety of intramuscularly administered AV0328. Approximately 16 subjects will be enrolled at a single U.S. center, based on 4 subjects per dose group. The study will consist of 3 parts: Part 1 will be a single dose, dose escalation study; Part 2 will assess the effect of a second dose of AV0328; Part 3 will assess the ability of a booster injection of AV0328 at Month 6 to restore protective titers against N. meningitidis B16B6 bacteria. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase IIa - CD-002[/INST] This is a randomized, double-blind, placebo controlled, safety, tolerability, and pharmacokinetic dose escalation Phase II study of DFA-02 in patients undergoing colorectal surgery to evaluate the safety, tolerability and pharmacokinetics of DFA-02. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - EINSTEIN-DVT[/INST] This is a multicenter, randomized, open-label, assessor-blind, event-driven, non-inferiority program for efficacy with a study treatment duration of 3, 6 or 12 months in patients with confirmed acute symptomatic DVT without symptomatic PE (Einstein-DVT). </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> Dry eye can be caused by many variable factors. Some examples include hormonal changes due to aging, or living in an environment of low humidity for long periods of time. Dry eye is a complex disease that may result in symptoms like discomfort, visual disturbance, and dryness. Patients with dry eye often have damage on the surface of the eye. In previous studies, RGN-259 has been shown to promote healing of the surface of the eye and decrease inflammation. It suggests that RGN-259 has a significant potential to be an important new safe and effective therapeutic in the treatment of dry eye syndrome. [/INST] The objective of this study is to compare the safety and efficacy of RGN-259 Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - Pediatric[/INST] This is a phase 3 open-label, one-arm, clinical study to evaluate the efficacy, safety and tolerability of setmelanotide over 1 year of treatment, in pediatric patients aged 2 to <6 years with obesity due to either biallelic variants of the POMC, PCSK1 or LEPR genes or Bardet-Biedl Syndrome (BBS). </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - Open-Label Extension (12 Weeks)[/INST] This is an open-label, extension trial designed to evaluate safety over 12 additional weeks of TNX-102 SL therapy taken daily at bedtime for the treatment of PTSD. Patients recruited into this trial are those who have successfully completed the double-blind lead-in study. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This is a Phase I/II, open label study in up to 12 subjects with telomere biology disorders with bone marrow failure. The study is open to all participants regardless of gender or ethnicity. Subjects who are enrolled but not evaluable will be replaced. Subjects will sign a consent form prior to any study related procedure and will complete baseline screening assessments. Subjects for this study will not require any preparative regimen such as chemotherapy or radiation. The study will be conducted in three parts - Peripheral blood mononuclear cells (PBMNCs) collection; mobilization and apheresis, - Ex vivo cell processing - Processed cell infusion and post-infusion safety monitoring, - Follow-up (Week 2, 3,4,5, Months 1, 2,3,4,5,6,9 and 12) [/INST] This is a Phase I/II, open label, single center study to assess the safety and tolerability of EXG34217 in bone marrow failure patients with telomere biology disorders. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> JKB-122 has been demonstrated effective reducing aminotransferase in refractory AIH patients with SOC.This is a new Phase 2 study to find an optimal dose for relevant phase 3 study in newly diagnostic AIH patients. All patients will receive prednisolone and AZA as standard of care (SOC) during the study. Subjects will be randomized to receive 5 mg JKB-122, 15 mg JKB-122, 35 mg JKB-122 or placebo in 1:1:1:1 ratio, adjunct to SOC. This protocol with the primary endpoint being biochemical remission and evaluation of 3 different treatment doses. The histology will be explored as secondary to test long term benefit and to show similar trend with the biomarkers. [/INST] This is a Phase 2 study. All patients will receive prednisolone and AZA as standard of care (SOC) during the study. At the end of the study, all data collected will be analyzed the efficacy and safety of JKB-122 on SOC reduction and inflammation improvement in Autoimmune Hepatitis </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> The purpose of this study is to examine a new chemical entity with 5HT agonist activity and an inhibition of the nitric oxide synthase enzyme (NOS) in patients suffering from migraine with aura. Nitric oxide has diverse roles both in normal and pathological processes including the regulation of blood pressure, neurotransmission, and macrophage defense systems. NO is synthesized by three isoforms of the NOS enzyme: neuronal (n), inducible (i) and endothelial (e). Neuronal NOS (nNOS) is found mainly in neuronal tissue and regulates changes in response sensitivity and cellular plasticity; iNOS is found in macrophages and other tissue, produces NO in response to stress and injury and is one source of inflammation; eNOS is found in endothelial cells, responsible for vascular homeostasis and the presumed mechanism for the effects of nitroglycerine therapy in angina; nitroglycerine is an NO donor. NXN-188 is selectively inhibits nNOS. There is ample scientific and clinical evidence that NO is involved in the pathogenesis of migraine pain, as well as other pain states characterized by central sensitization (e.g., neuropathic pain). NO donors such as trinitroglycerine induce headache followed by migraine in migraineurs with or without aura ; moreover, platelet nitrates (a signal for increased NO) increase before and during a migraine attack. In addition, increasing NO levels can enhance pain responses in animals, including allodynia in rats; NO is a component of several pathways where pain systems converge in the PNS and CNS and regulates the activity of numerous transmitter systems ; NO is involved in central sensitization particularly those involving NMDA and calcium channels and thought to be a major component of the formation of neuropathic pain states Non-specific NOS inhibitors have been reported to relieve migraine and chronic tension type headaches in human studies. In animals, NOS inhibitors reduce pain-related behaviors in multiple neuropathic pain models and spinal cord ischemia as well as reducing pain related behaviors in chemically-induced pain models, particularly in secondary pain states. The development of central sensitization in the course of a migraine attack suggests a role for the neuronal isoform of the NOS enzyme. NXN-188 can bind to both 5-HT1D and 5-HT1B receptors with potency similar to sumatriptan; it also selectively binds to nNOS with a level of nNOS inhibition similar to L-NMMA. NXN-188 is devoid of any relevant eNOS inhibition in in vitro cloned human enzyme assays or ex vivo in human coronary arteries and is expected to be effective in treating migraine by inhibition of the nNOS enzyme without vasoconstrictive effects associated with non-selective compounds such as L-NMMA. The following study is being conducted to further explore NXN-188 response in subjects with a migraine history of aura. In this study subjects will treat two attacks of migraine with aura during the aura phase - once with placebo and once with NXN-188. [/INST] The following study is being conducted to explore the safety and effectiveness of a new chemical entity called NXN-188 in subjects with a history of migraine with aura. In this study subjects will treat two attacks of migraine with aura during the aura phase - once with placebo and once with NXN-188. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Dose-Finding Study (US/Canada)[/INST] This is a clinical investigation approved by US FDA and Canadian Health Authority to study the safety and potential effectiveness of the autologous muscle cells for the treatment of stress urinary incontinence. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - POETYK-PSO-2[/INST] The purpose of this study is to investigate the experimental medication BMS-986165 compared to placebo and a currently available treatment in participants with moderate to severe plaque psoriasis. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This first-in-human trial with ABL001 is a dose escalation study whose primary purpose is to estimate the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of single agent ABL001 in CML or Ph+ ALL patients, and in combination with either Nilotinib or Imatinib or Dasatinib in Ph positive CML patients. The safety, tolerability and pharmacokinetic (PK) profile of ABL001 and ABL001+Nilotinib, ABL001+Imatinib and ABL001+Dasatinib will be assessed together with an evaluation of pharmacodynamic (PD) changes in peripheral blood mononuclear cells (PBMC) and bone marrow aspirates and all data may contribute to the assessment of the RDE. An understanding of the MTD/RDE, safety profile, PK/PD relationship, and preliminary evidence of anti-CML and ALL activity will be used to inform future development in adults with CML and Ph+ ALL. By virtue of its distinct pharmacological profile and by preclinical pharmacological studies demonstrating an additive effect, a combination of ABL001 and a tyrosine-kinase inhibitor (TKI) has the potential to achieve a deeper molecular response in a higher proportion of CML patients as compared to single agent TKI therapy. Such a combination has the added advantage of targeting the ABL kinase domain at two distinct locations, theoretically preventing single point mutation-associated treatment resistance. The prediction is that a nilotinib+ABL001, imatinib+ABL001 and/or dasatinib+ABL001 combination will increase the percentage of patients who achieve a complete molecular response (CMR) and decrease the time to CMR, thereby increasing the possibility of achieving sustained treatment-free remissions in these patients. In addition, some patients may be intolerant of therapy with TKIs or may develop mutations that promote resistance to TKI therapy. In these patients, ABL001 may provide a novel therapeutic option. [/INST] The design of a phase I, open label, dose finding study was chosen in order to establish a safe and tolerated dose of single agent ABL001 in CML and Ph+ ALL patients who are relapsed or refractory to or are intolerant of TKIs, and of ABL001+Nilotinib, ABL001+Imatinib and ABL001+Dasatinib in Ph positive CML patients who are relapsed or refractory to TKIs. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - vs. Avastin (Healthy Volunteers)[/INST] The purpose of this study is to confirm pharmacokinetic equivalence and compare clinical safety profile of RPH-001 and Avastin®. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - 201MEL - PK/PD[/INST] This is a global, Phase 2, open label, dose selection, proof-of-concept study to assess progression free survival in subjects with metastatic melanoma. Approximately 80 subjects at 29 sites in the U.S., U.K., Germany and Australia will be randomized into one of two dose groups: 2 mg/kg, 4 mg/kg. Weekly treatment will continue until disease progression. Subjects must have measurable disease by CT Scan or MRI and must have completed at least one prior round of chemotherapy. Subjects will be assessed for Efficacy, PK/PD, Overall survival, and Safety (Adverse Events/Adverse Events of Interest, Electrocardiograms (ECG's), clinical labs, physical exams/vital signs, tolerability). </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase Ia - SAD/MAD (IV/SC)[/INST] The study will evaluate the safety of LY3002813 by looking at adverse events. The study will also look at the effect the body has on LY3002813. Study participants will be healthy or will have mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild to moderate AD. There will be seven groups of study participants. Five groups will receive a single dose of LY3002813 or placebo (no drug), followed by up to 4 multiple doses of LY3002813 or placebo given as an injection into a vein. Approximately 12 weeks will pass between the single dose and the first multiple dose. One group of participants will receive a single dose of LY3002813 given as an injection under the skin. One group of participants will receive a single dose of LY3002813 given as an injection into a vein. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - ARCADE (Low Risk MDS)[/INST] The primary objective was to assess the superiority of darbepoetin alfa versus placebo on the incidence of red blood cell transfusions during the 24-week double-blind treatment period in anemic patients with low or intermediate-1 risk MDS. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - CARBON[/INST] This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX110 in subjects with relapsed or refractory B-cell malignancies. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - Peritoneal Cancer (MSKCC)[/INST] A phase I study of Intraperitoneal Radioimmunotherapy with 131 I-omburtamab in patients >1 year of age with desmoplastic small round cell tumors and other solid tumors involving the peritoneum. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - Ha03-001[/INST] The purpose of the study was to assess the efficacy, safety and tolerability of a single application of abametapir lotion 0.74% w/w compared to a vehicle control, when applied to the scalp and hair for 10 minutes at home. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - POWER1[/INST] The purpose of this study is to determine if the investigational drug GTx-024 can help subjects with non-small cell lung cancer increase physical function and maintain or gain muscle, also called "lean body mass". </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase Ib/III - IMnscin[/INST] This study will evaluate the pharmacokinetics, safety, and efficacy of atezolizumab subcutaneous (SC) compared with atezolizumab intravenous (IV) in participants with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) who have not been exposed to cancer immunotherapy (CIT) and for whom prior platinum-based therapy has failed. The study is comprised of two parts, as follows: A dose-finding part (Part 1, Phase Ib) will aim to identify the dose of atezolizumab SC to be tested in Part 2. A dose-confirmation part (Part 2, Phase III, randomized) will aim to confirm that the dose moved forward from Part 1 yields drug exposure that is comparable to that of atezolizumab IV. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> A-dmDT390-bisFv(UCHT1) (Resimmune™), an anti-T cell immunotoxin is currently being studied as a treatment for cutaneous T cell lymphoma and other CD3+ malignant diseases (FDA IND Number: 100712, Scott and White Protocol 071163). During the course of this study, data accumulated that Resimmune could be acting as an immunomodulator. This was based on the observation that four out of six partial responses converted to complete responses at times ranging between 6 and 24 months following the completion of the 4-day treatment protocol and no other treatment took place. The purpose of this trial is to test the hypothesis that Resimmune can act as an immunomodulator of late stage metastatic melanoma when combined with palliative radiation to induce the priming of activated T cells with tumor antigens. The primary objective of this study is to determine the safety of combining Resimmune with palliative radiation therapy in patients with stage IV melanoma. A secondary objective is to document the tumor response and duration of response at irradiated and unirradiated sites (the abscopal effect). An additional secondary objective is to determine if T cell activation occurs following administration of A-dmDT390-bisFv(UCHT1) and local radiation to a metastatic lesion of melanoma. [/INST] The purpose of this trial is to study A-dmDT390-bisFv(UCHT1) in combination with ionizing irradiation for the treatment of stage IV melanoma, a disease that is essentially incurable with median overall survival periods that range from 8-16 months. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - Sweden[/INST] Medical Products Agency </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II[/INST] The purpose of this study is to investigate the effectiveness and safety of 12 weeks of treatment with R256918 in patients with Type 2 Diabetes Mellitus who are taking metformin. The primary measure of effectiveness is the change in concentration of glycated hemoglobin (HbA1c) during treatment. Glycated hemoglobin is a substance in red blood cells that is formed when blood sugar (glucose) attaches to hemoglobin and is a measure of diabetic status. Additional measures include fasting glucose, and lipid levels, and body weight. Safety assessments performed during the trial include laboratory tests, vital sign measurements, and adverse event reporting. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - 205.420[/INST] Rationale for the current trial is to demonstrate 24 hour bronchodilator efficacy and safety of tiotropium 5 µg administered once daily (in the evening) which is regarded beneficial for the compliance and convenience of the patient in comparison to placebo. Further the rationale is to evaluate efficacy and safety of tiotropium 2.5 µg administered twice daily delivered by the Respimat® inhaler in comparison to placebo and tiotropium 5 µg administered once daily (in the evening) delivered by the Respimat® inhaler in patients with moderate persistent asthma. Rationale for the pharmacokinetic subinvestigation is to evaluate the 24 hours exposure to tiotropium in patients with moderate persistent asthma when administered 5 µg tiotropium once daily (in the evening) or 2.5 µg tiotropium twice daily. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This Phase 2 first-in-neonate EDI200 study will enroll treatment-naïve, XLHED-affected male newborns in the first two weeks of life. All subjects will meet entry criteria including documentation of an EDA mutation associated with XLHED. Following Baseline evaluations, EDI200 dosing will be initiated between day-of-life 2 and 14, with each study subject receiving 2 doses/week for a total of 5 doses. This dosing regimen mirrors that used to enhance efficacy in the dog XLHED model, considered to be most relevant to the clinical study design. The study will enroll subjects in two cohorts with subjects in cohort 1 dosed at 3 mg/kg/dose, associated with partial efficacy, and cohort 2 dosed at 10 mg/kg/dose where enhanced efficacy was demonstrated in the most relevant preclinical model. Given the challenge of identifying families where the subject is yet to be born, it is expected that cohort size and time for recruitment will be variable. The sponsor anticipates enrollment and dosing of 6-10 subjects over a 12-18 month period, 3-5 subjects per cohort. [/INST] This Phase 2 first-in-neonate EDI200 study will enroll treatment-naïve, XLHED-affected male newborns in the first two weeks of life. All subjects will meet entry criteria including documentation of an Ectodysplasin (EDA) mutation associated with XLHED. Following Baseline evaluations, EDI200 dosing will be initiated between day-of-life 2 and 14, with each study subject receiving 2 doses/week for a total of 5 doses. The study will enroll subjects in two cohorts with subjects in cohort 1 dosed at 3 mg/kg/dose, associated with partial efficacy, and cohort 2 dosed at 10 mg/kg/dose where enhanced efficacy was demonstrated in the most relevant preclinical model. Given the challenge of identifying families where the subject is yet to be born, it is expected that cohort size and time for recruitment will be variable. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I/II - Dose-Finding (PC CO201/08)[/INST] The purpose of the study is to determine if it is possible to detect more pre-cancerous lesions in colon when using fluorescence technology. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - CLC-102[/INST] The purpose of this study is to determine the safety, tolerability, dose limiting toxicities, and maximum tolerated dose of CB-5083 in subjects with lymphoid hematological malignancies. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - Healthy Volunteers[/INST] This study is the second human clinical study with PRTX-100. It is designed to assess the safety of a single intravenous (IV) dose of PRTX-100, as well as, how the drug is eliminated from the blood after dosing. Additionally, this study provides an opportunity to monitor immune system response to PRTX-100. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - 01[/INST] Open-label Phase 1 study of AutoSynVax™ vaccine with QS-21 Stimulon® adjuvant in subjects with advanced cancer </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> The drug tested in this study was called ixazomib (MLN9708). Ixazomib was tested to treat the people with newly diagnosed multiple myeloma requiring systemic treatment who were not eligible for stem cell transplantation. This study determined the safety, tolerability, efficacy, quality of life (QOL), and pharmacokinetics (PK)/pharmacodynamics (PD) of ixazomib. The study enrolled 61 patients. The study was conducted in 2 parts: 1) phase 1 dose escalation and 2) phase 2 expansion at maximum tolerated dose. Participants were enrolled to receive: - Ixazomib 3.0 mg, 3.7 mg, 4.0 mg, or 5.5. mg depending on the treatment assignment This multicenter trial was conducted in the Unites states, Canada, United Kingdom, Spain and Czech Republic. The overall time to participate in this study is 5.5 years. Participants made multiple visits to the clinic and were followed up every 16 weeks after end of treatment until disease progression if stopped treatment before disease progression and then every 16 weeks up to start of next therapy or death whichever occurs first. [/INST] The purpose of this phase 1/2, open-label study was to evaluate the effect of oral formulation of Ixazomib when added to standard melphalan and prednisone (MP) treatment. Both phases of the study included participants who had newly diagnosed multiple myeloma and were ineligible for high-dose therapy plus stem cell transplantation because of age (≥65 years of age) or coexisting conditions and for whom standard MP treatment was indicated. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - Relapsed/Refractory[/INST] The Phase 1 primary objectives of this study were to assess the safety profile, characterize pharmacokinetics (PK) and determine the dosing schedule, maximum tolerated dose (MTD), and recommended Phase 2 dose (RPTD) of ABT-199 (venetoclax) when administered in participants with relapsed or refractory multiple myeloma. This study also assessed the safety profile and PK of venetoclax in combination with dexamethasone in participants with t(11;14)-positive multiple myeloma. The Phase 2 primary objective was to further evaluate the objective response rate (ORR) and very good partial response or better rate (VGPR+) in participants with t(11;14)-positive multiple myeloma. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - 1204 Study[/INST] This is a randomized, double-blind, vehicle-controlled, Phase 2 study in subjects with moderate AD. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> The maximum duration for GLP1-RA participants was approximately 29 weeks: up to 2 week screening period, a 26 week treatment period (either randomized or uncontrolled), and a 3 or 9 day post-treatment safety follow-up period. Maximum duration for FRC participants was approximately 55 weeks: up to 2-week screening period, a 26-week randomized treatment period, a 26-week extension period and a 3-day post-treatment safety follow-up period. All primary and secondary efficacy, safety and other outcome measures were assessed at the end of the extension period. [/INST] Primary Objective: To demonstrate the superiority of the insulin glargine/lixisenatide fixed ratio combination (FRC) versus GLP-1 receptor agonist (GLP-1 RA) in hemoglobin A1c (HbA1c) change. Secondary Objectives: To compare the overall efficacy and safety of the insulin glargine/lixisenatide FRC to GLP-1 RA on top of metformin (with or without pioglitazone, with or without sodium-glucose co-transporter 2 [SGLT2] inhibitor) in participants with type 2 diabetes. To evaluate safety, efficacy and other endpoints of FRC up to the end of the extension period. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - w/Lipitor (12 weeks) (DFI11565)[/INST] Primary Objective: - To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein cholesterol (LDL-C) levels after 12 weeks of treatment in comparison with placebo in participants with LDL-C ≥ 100 mg/dL (≥ 2.59 mmol/L) on ongoing stable atorvastatin therapy. Secondary Objectives: - To evaluate the effects of alirocumab on other lipid levels after 12 weeks of treatment in comparison with placebo - To evaluate the safety and tolerability of alirocumab - To evaluate the development of anti-alirocumab antibodies - To evaluate the pharmacokinetics of alirocumab </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> The primary objective of this study is to evaluate the efficacy of 10% (150 mg) lidocaine gel compared with placebo in reducing the severity and onset of primary dysmenorrhea in women with recurrent dysmenorrhea. The secondary objectives of this study are the following: - to assess the safety of 10% (150 mg) lidocaine gel compared with placebo - to evaluate electrocardiograms (ECGs) for potentially significant QT changes at approximate peak lidocaine plasma concentration after 4 days of dosing with 10% (150 mg) lidocaine gel. [/INST] The purpose of this study is to determine whether lidocaine vaginal gel is safe and effective for preventing or reducing the severity of dysmenorrhea (painful menstrual periods) compared to placebo (inactive gel). </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - RE-ARRANGE (Spanish Cooperative Group TTD)[/INST] The purpose of this study is to assess the safety and tolerability of different dose-escalation approaches of regorafenib in mCRC patients. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - Mountain Cedar Pollen[/INST] This study will assess the efficacy and safety of ACT-129968 in adolescent, adult and elderly patients with seasonal allergic rhinitis, due to mountain cedar pollen. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> The study is a 9-month, randomized, double-blind, parallel-design study of subjects with existing moderate to severe periodontal disease randomly assigned to one of three groups. The primary endpoint of PD change will be evaluated following 9 months of treatment. Subjects will be followed for 9 months for safety and radiographic evaluations. Subjects who meet inclusion criteria will be randomized to one of three treatment groups. Randomization will be stratified by site and smoker status (never smoked or quit smoking more than two years ago vs. has smoked within the last two years). Randomization will be blocked such that assignment to treatment groups both within sites and within smoker status will be approximately even (1:1:1). Treatment will be initiated after SRP. All subjects will be evaluated at baseline and Days 1, 15, 30, 60, 90, 180, and 270. [/INST] The purpose of this study is to determine whether ST266 will reduce pocket depth (PD) as an adjunctive to scaling and root planing (SRP) in subjects with moderate to severe periodontal disease. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> PRIMARY OBJECTIVES: I. To determine the safety profile of the HCV DNA vaccine, consisting of INO-8000 (HCV antigen DNA) alone or co-administered with INO-9012 (interleukin [IL]-12 adjuvant DNA) (DNA plasmid encoding interleukin-12 INO-9012). II. To identify a dose of INO-9012 (IL-12 adjuvant DNA) for co-administration with INO-8000 (HCV antigen DNA) based on induction of HCV-specific interferon (IFN)-gamma production by peripheral blood mononuclear cells at 26 weeks compared to baseline in HCV-infected participants. TRANSLATIONAL OBJECTIVES: I. Determine the rate at which INO-8000 with different doses of INO-9012 induces a > 1 log decrease (or undetectable) in HCV ribonucleic acid (RNA) level at weeks 14 and 26. II. Determine the rate at which INO-8000 with different doses of INO-9012 induces an end-of-treatment undetectable HCV RNA (end-of-treatment virologic response - EVR) at 26 weeks and a sustained virologic response (SVR) at 36 weeks. III. Determine the rate at which INO-8000 with different doses of INO-9012 induces other parameters of cluster of differentiation (CD)8 and CD4 T lymphocyte responses as measured by flow cytometry, and antibody responses to HCV antigen at weeks 14 and 26. OUTLINE: This is a dose-escalation study of INO-9012. Patients receive INO-8000 intramuscularly (IM) and DNA plasmid encoding interleukin-12 INO-9012 IM (dose levels 2-4) followed by electroporation (EP) at day 0 and at weeks 4, 12, and 24. After completion of study treatment, patients are followed up at weeks 48 and 76. [/INST] This phase I trial studies the side effects and best dose of deoxyribonucleic acid (DNA) vaccine therapy in treating patients with hepatitis C virus (HCV) infection that persists or progresses over a long period of time. Vaccines made from DNA may help the body build an effective immune response to kill cancer cells that express HCV infection. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> Per protocol, all participants who were receiving study intervention or in survival follow-up could enroll in the extension study, KEYNOTE-587 (NCT03486873), which would allow further study participation after the Primary Completion Date cut-off. Thus, all efficacy outcome measures except for survival (Overall Survival [OS]) were to be followed up to the Interim Database cut-off of 18-Sept-2018, and the primary safety analyses (except for the DLT analysis) and Overall Survival were to be followed up to the study Primary Completion Date (Final Database cut-off of 05-Nov-2018). Five participants did not have end of study assessments completed by the Primary Completion Date cut-off and were subsequently followed up to the Study Completion Date (11-Dec-2018). End of treatment and end of study assessments are missing for these 5 and the status was noted as unknown as of the Primary Completion Date cut-off. Per protocol, any safety information after the Primary Completion Date cut-off (Final Database cut-off of 05-Nov-2018) would not be included in the safety analysis but reported by the Investigator to the Sponsor via the Sponsor Communication Form and filed in the electronic Trial Master File. [/INST] The present study has 5 parts. In Parts A and A1, the dose of intravenous (IV) pembrolizumab (MK-3475) will be escalated from 1 to 10 mg/kg to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) for participants with a histologically- or cytologically-confirmed diagnosis of any type of carcinoma or melanoma (MEL) by evaluating the Dose Limiting Toxicities (DLTs). Following completion of the dose escalation, additional patients will be enrolled in Part A2 to further define pharmacokinetic characteristics. Part B of the study will investigate the safety, tolerability, and efficacy of pembrolizumab (2 mg/kg and 10 mg/kg) in participants with advanced or metastatic MEL and compare every 2 week dosing (Q2W) to every 3 week dosing (Q3W). Part C of the study will investigate the safety, tolerability, and efficacy of pembrolizumab administered at 10 mg/kg Q3W in participants with non-small cell lung carcinoma (NSCLC) that is locally advanced or metastatic. Part D of the study will investigate the low and high doses of study drug identified in Parts A and B (2 mg/kg and 10 mg/kg) administered Q3W in participants with advanced or metastatic MEL. Part E (closed with Amendment 7) was planned to investigate low, medium, and high doses of pembrolizumab in combination with standard chemotherapy in participants with locally advanced or metastatic NSCLC. Part F will investigate low and high doses of pembrolizumab (2 mg/kg and 10 mg/kg) administered Q2W or Q3W in treatment-naive and previously-treated participants with NSCLC with programmed cell death 1 ligand (PD-L1) gene expression. The primary hypotheses are the following: that pembrolizumab will have acceptable safety and tolerability; that pembrolizumab will show a clinically meaningful response rate (RR) or disease-control rate (DCR) in participants with melanoma (ipilimumab-refractory or not) and NSCLC, and that pembrolizumab will show a more clinically meaningful RR in participants with either cancer whose tumors express PD-L1. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase IIIb - COMRADE-B (Branch RVO)[/INST] This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone implant after 6 months of treatment. In the study arm Ranibizumab will be given monthly in a pro re nata scheme whereas the comparator Dexamethasone implant is given once at Month 0 with sham injections PRN afterwards. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase Ib/II - w/Rituxan[/INST] This Phase Ib/II, open-label, multicenter trial is designed to evaluate the safety, pharmacokinetics, and efficacy of dulanermin when combined with rituximab in subjects with follicular, CD20+, B-cell Non-Hodgkin's Lymphoma (NHL) that has progressed following a response of ≥ 6 months duration to a prior rituximab-containing therapy. The multicenter, international, randomized Phase II part of this study will commence only after the safety and available pharmacokinetic data from the Phase Ib part of the study have been evaluated by the Sponsor and have been provided to participating investigators and the FDA. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase IIa - ION04[/INST] To evaluate the safety and efficacy of a single intracavernous injection of hMaxi K (8000 µg and 16000 µg) or placebo upon penile rigidity or erection in males with erectile dysfunction longer than six months that is attributable to an underlying, stable medical condition. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - PENGUIN 1[/INST] The primary objective of this study is to evaluate the effect of filgotinib compared to placebo as assessed by the American College of Rheumatology 20% improvement (ACR20) response in participants with active psoriatic arthritis who are naive to biologic disease-modifying anti-rheumatic drug (DMARD) therapy. The study consists of two parts, the Main Study and the Long Term Extension (LTE). </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This is a randomized, double-blind, double dummy, parallel group, multicenter 24 to 52 week variable length study to assess the efficacy and safety of budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler (MDI) relative to budesonide and formoterol fumarate MDI and Symbicort® pressurized MDI in adult and adolescent participants with inadequately controlled asthma. Approximately 2200 participants will be randomized globally. [/INST] This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> The purpose of this study is to evaluate both the safety and efficacy of ixekizumab dosing regimens. There are 3 study periods: Screening Period, Blinded Treatment Dosing Period, and Post-Treatment Follow-Up. [/INST] The main purpose of this study is to evaluate the efficacy of ixekizumab dosing regimens in participants with plaque psoriasis. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase Ib/II - KEYNOTE-184 (w/SD-101)[/INST] This is a phase 1b/2, open-label, multicenter trial designed to evaluate the safety, tolerability, biologic activity, and preliminary efficacy of intratumoral SD-101 injections in combination with intravenous pembrolizumab in patients with metastatic melanoma or recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). This study will be conducted in 2 phases. Phase 1 evaluates SD-101 given in combination with pembrolizumab in melanoma populations (anti-PD-1/L1 naïve and anti-PD-1/L1 experienced with progressive disease) in up to 4 Dose Escalation cohorts to identify a recommended Phase 2 dose (RP2D) to be evaluated in up to 4 Dose Expansion cohorts in Phase 2. Phase 2 also includes up to 4 Dose Expansion cohorts of patients with HNSCC (anti-PD-1/L1 naïve and anti-PD-1/L1 experienced with progressive disease). </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared with Placebo on 24-hour Glucose Control in 110 Metformin-treated Patients with Type 2 Diabetes [/INST] A Randomized, Double-blind, Parallel-group Study to Evaluate the Effect of Bydureon Compared with Placebo on 24-hour Glucose Control in Metformin-treated Patients with Type 2 Diabetes. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> The drug being tested in this study is called febuxostat extended-release (XR). Febuxostat XR is being tested to assess if antacids affect how the drug moves throughout the body. This study will look at lab safety and side effects in people who take febuxostat XR. This cross-over study will enroll approximately 36 patients. Participants will be randomly assigned to one of four treatment sequences. All participants will receive the following study medications by the end of the study: - Febuxostat XR 80 mg capsules - Maalox Advance Regular Strength liquid containing Aluminum Hydroxide 200 mg, Magnesium Hydroxide 200 mg, and Simethicone 20 mg/5 mL or equivalent All participants will be administered one dose of one or both of the study medications on Day 1 of four separate study periods. This single-centre trial will be conducted in the United States. The overall time to participate in this study is up to 84 days. Participants will make 5 visits to the clinic including four 4-day periods of confinement to the clinic, and will be contacted by telephone 30 days after last dose of study drug for a follow-up assessment. [/INST] The purpose of this study is to assess the effect of antacid administration, and its timing, on the bioavailability of a single dose of febuxostat extended-release (XR) 80 mg. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - w/Gefitinib[/INST] This study has two parts: dose escalation and dose expansion. The primary objectives are: - For Dose Escalation, to assess the safety and tolerability of DS-1205c when combined with gefitinib in the study population and to determine the recommended dose for expansion of DS-1205c when combined with gefitinib in the study population - For Dose Expansion, to assess the safety and tolerability of DS-1205c when combined with gefitinib in the study population. In Dose Escalation, after a 7-day run in period (Cycle 0), there will be 21-day cycles (Cycle 1 onward). In Dose Expansion, there will be 21-day cycles. The number of treatment cycles is not fixed in this study. Participants will continue study treatment for 36 months unless they decide not to (withdraw consent), their disease gets worse [progressive disease (PD)], or side effects become unacceptable (unacceptable toxicity). </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> Cytarabine in combination with an anthracycline is a frequently used chemotherapy platform for both newly diagnosed and relapsed/refractory acute myeloid leukemia (AML) and other hematologic malignancies. Synergistic antitumor activity has been demonstrated between cytarabine and daunorubicin that is dependent upon the ratio of the drugs with the best therapeutic effect observed with a cytarabine to daunorubicin ratio of 5:1 in in vitro and in vivo models. CPX-351 is a liposomal preparation of cytarabine and daunorubicin that maintains this therapeutic drug ratio 24 hours post infusion. The altered biodistribution from encapsulation may result in a greater therapeutic effect in patients with relapsed hematologic malignancies and demonstrate greater tolerability than non-liposomal cytarabine and daunorubicin. This is a single institution phase-I pilot study that aims to assess the pharmacokinetics, toxicity and tolerability of CPX-351 in pediatric and young adults with relapsed/refractory hematologic malignancies. Subjects will receive a single course of CPX-351 administered on Days 1, 3, and 5. The study will first open to children in a dose exploration phase, and then be available to an expanded cohort, which will be open to children and young adults once a tolerable dose has been determined. [/INST] The purpose of this study is to test the safety of a study drug called CPX-351. This drug has been tested in adults but not yet in children and adolescents. This study tests different doses of the drug to see which dose is safer in children and adolescents. Patients who have blood cancer are being asked to take part in this study . Blood cancers may include leukemia and lymphoma. Patients able to be in this study have already been treated with standard chemotherapy for their disease and the disease is still growing or has come back. CPX-351 is a drug that is not yet approved by the United States Food and Drug Administration (FDA) and is only used in research studies like this one. CPX-351 is made up of two chemotherapy drugs that patients may have already received called cytarabine and daunorubicin that are now packaged together. Another purpose of this study is to collect blood samples for special research studies. Researchers want to study how much of the CPX-351 is in the body over time. These studies are call pharmacokinetic studies or PK studies for short. PK studies require the collection of several blood samples before and after participants are given the study drug. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - Study 004 Ext.[/INST] This study is a 12-month, dose-level blinded, multicenter study of 2 inhaled dose levels of CVT-301 for the treatment of up to 5 OFF episodes per day in PD patients experiencing motor fluctuations (OFF episodes). All patients will receive active treatment, but patients will be blinded to dose level. This will serve as an extension to the CVT-301-004 (NCT02240030) study for those patients who participated in that study and remain eligible for this study. In addition, patients who previously completed the CVT-301-003 (NCT01777555), CVT-301-009 (NCT02807675) and CVT-301-005 (NCT02352363) (observational arm completers), as well as CVT-301 naïve patients may be enrolled if they meet the CVT-301-004E eligibility criteria. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - w/mLSG15 (Japan)[/INST] This is a multicenter, randomized, open-label, parallel-group study to compare mLSG15 + KW-0761 to mLSG15 in subjects with CCR4-positive adult T-cell leukemia-lymphoma (untreated primary disease). The primary variable is an efficacy of KW-0761 used as an add-on therapy to mLSG15 as measured in terms of complete response rate (CR/CRu) in the best overall response assessment for antitumor effect. The secondary variables include response rate (CR/CRu/PR) in the best overall response assessment for antitumor effect, complete or response rates by lesion site in the best overall response assessment for antitumor effect, progression-free survival and overall survival. The safety and pharmacokinetic profiles of KW-0761 will be also determined. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase Ib - J-MIND (Japan)[/INST] This is an open-label, multicenter study to evaluate safety and tolerability, determine the RP2Ds of tafasitamab alone in Japanese participants with R/R NHL, or to evaluate efficacy and safety of tafasitamab in combination with lenalidomide in Japanese participants with R/R DLBCL, or tafasitimab in combination with lenalidomide plus R-CHOP in Japanese participants with previously untreated DLBC, or tafasitimab in combination with lenalidomide in Japanese participants with previously R/R DLBC. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - Japan[/INST] The purpose of this study is to evaluate the efficacy of Levetiracetam (LEV) used as monotherapy, with efficacy measured as 6-month seizure freedom at the last evaluated dose in the LEV 1000 mg/day to 2000 mg/day group, in newly or recently diagnosed epilepsy subjects. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - ARS[/INST] This Phase 3, multicenter, open-label study of chronic, intermittent use of study drug (DBF) is designed to evaluate the safety and tolerability of the buccal formulation of diazepam in children, adolescents and adults with intermittent, stereotypic episodes of frequent seizure activity (eg, seizure clusters) that are distinct from the subject's usual seizure pattern. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> Eligible participants will receive single doses of HEPLISAV-B® at Weeks 0, 4, 8, and 16 and will be followed through Week 68 or end of study (EOS). The study is designed to evaluate the immunogenicity over a 20-week period and safety over a 68-week period. [/INST] This is an open-label, single arm study design to evaluate HEPLISAV-B® in adults with ESRD who are initiating or undergoing hemodialysis. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This is a phase 3 multi-center, randomized, double-blind, vehicle-controlled, parallel group study to be conducted in up to approximately 850 subjects 6 months of age and older with molluscum contagiosum (MC). After obtaining informed consent/assent, subjects who satisfy entry criteria will be randomized 1:1 (active:vehicle). Subjects receiving current treatment for MC at the time of the Screening Visit will enter a wash out period of up to 14 days prior to randomization. Subjects or their caregivers will apply treatment once daily to all lesions identified at Baseline and new lesions that arise during treatment for a minimum of 4 weeks and up to 12 weeks. If the investigator determines all lesions are cleared at a visit, the treatment may stop. If treatment is stopped due to clearance, subjects will continue regularly scheduled visits through Week 24/ET2. Study drug will be dispensed through Week 12/ET1 in case of lesion recurrence between study visits. At each visit subsequent to stopping treatment due to clearance, the investigator will determine if new lesions have occurred since the last visit, and if so, the subject or caregiver will be instructed by the investigator to re-initiate treatment. If the subject or caregiver see new lesions or re-occurrence of lesions in between visits, they should treat these lesions until the next visit. No study drug will be provided after the Week 12 visit. The subject or caregiver will apply study drug to the individual lesions. Periocular lesions will be treated if the lesions are at least 2 cm from the edge of the eye. Subjects will visit the clinic in person at Screening/Baseline, Week 2, Week 4 (unless visit is performed remotely), Week 8, Week 12, and Week 24. [/INST] This is a phase 3 multi-center, randomized, double-blind, vehicle-controlled, parallel group study to be conducted in up to approximately 850 subjects 6 months of age and older with molluscum contagiosum (MC). Subjects or their caregivers will apply SB206 10.3% or Vehicle Gel once daily for a minimum of 4 weeks and up to 12 weeks to all lesions identified at Baseline and new treatable lesions that arise during the course of the study. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - NY-ESO-1[/INST] This is a Phase 1 multi-center study to evaluate the clinical safety and immune response of ID-LV305 when injected intradermally in patients with advanced cancer. ID-LV305 is a novel immunotherapy agent designed to target dendritic cells and stimulate the body's immune system to fight the spread and growth of cancer for patients whose tumors express the NY-ESO-1 protein. Patients with melanoma, sarcoma, ovarian cancer, or small cell lung cancer that express NY-ESO-1 may be considered for the trial. Selected sites will be evaluating ID-LV305 with pembrolizumab for patients with melanoma who have inadequately responded to anti-PD-1 therapy. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> Dose escalation / regimen exploration phase During the dose escalation/regimen exploration phase, only patients diagnosed with locally advanced or metastatic melanoma, carcinoma or sarcoma of any tumor type who are refractory or intolerant to all available therapies that would impact survival will be enrolled. ST101 will be administered intravenously (IV), initially once per week. The dose escalation cohorts will be recruited using a standard 3+3 design. At each new dosing cohort, there will be a 1-week observation period after dosing the first patient in order to assess safety prior to dosing the remainder of the patients in that cohort. The dose cohorts will be 0.5, 1, 2, 4, 8 and 16 mg/kg with once weekly (QW) dosing in all cohorts except for the highest dose level which will be dosed every other week (Q2W). The expansion phase consists of 4 specific tumor-type cohorts, which each follow the same Simon 2-stage design. Fifteen (15) patients will be enrolled in each cohort and treated with the ST101 RP2D. If one or more responses is observed that cohort will be expanded to a total of 30 patients to further assess efficacy. Responses will be graded using response evaluation criteria in solid tumors (RECIST) 1.1 (Eisenhauer 2009) for hormonal receptor positive (HRpos) locally advanced/metastatic breast cancer (LA/MBC) and melanoma, modified response assessment in neuro-oncology (RANO) (Ellingson 2017) for GBM and prostate cancer clinical trials working group 3 (PCWG3) (Scher 2016) for castration-resistant prostate cancer (CRPC).During the expansion phase, only patients diagnosed with the following tumor types will be allowed into this phase of the study: - HRpos LA/MBC that has progressed after prior 1-2 hormone-based therapies. Previous treatment with cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, mammalian target of rapamycin (mTOR) inhibitor or chemotherapy is allowed as monotherapy or in combination. - Melanoma that has progressed after/or on treatment with an immune checkpoint inhibitor (CPI) and have received 1-2 prior lines of therapy for their advanced/metastatic disease. Patients that have BRAF mutated disease should also have received one line of appropriate targeted therapy. - Primary (de novo) GBM that has recurred or progressed (per modified RANO criteria) after 1 standard treatment regimen. Standard therapy is defined as maximal surgical resection, radiotherapy, and concomitant temozolomide with radiotherapy or adjuvant chemotherapy with temozolomide. Patients that undergo tumor treating fields as an adjuvant to first line therapy are allowed. - CRPC that has progressed after previous treatment with taxanes, abiraterone and enzalutamide/apalutamide. The tumor types in the expansion phase may change based on emerging data from the dose escalation phase of this study. Additional mini cohorts of 10 patients may be added to the expansion phase based on efficacy signals during the dose escalation phase. [/INST] This is an open-label, two-part, phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 administered IV in patients with advanced solid tumors. The study consists of two phases: a phase 1 dose escalation/regimen exploration phase and a phase 2 expansion phase. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - Healthy Volunteers[/INST] The objectives of this study are to determine the safety and tolerability of single oral doses of STX107 and to determine basic pharmacokinetic (PK) parameters following single oral doses of STX107 when administered via an oral suspension </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - AGTC-AAT-002[/INST] Assessment of the safety and efficacy of intramuscular (IM) administration of a recombinant adenoassociated virus (rAAV) alpha-1 antitrypsin (AAT) vector (rAAV1-CB-hAAT) in AAT-deficient adults at three dosage levels [6.0 × 10e11, 1.9 × 10e12 and 6.0 × 10e12 vector genome particles (vg) per kg body weight]. Funding Sources - The FDA Office of Orphan Products Development and NIH National Heart, Lung, and Blood Institute </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - CARDIOMESH (Spain)[/INST] It´s a first open-label trial in humans to evaluate the safety and efficacy of epicardial delivery of collagen patches with adipose-derived stem cells in patients with ischemic heart disease and left ventricular dysfunction that remain symptomatic despite optimal medical treatment. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> The drug being tested in this study is called Ramelteon. Ramelteon is being tested to treat people who have Bipolar 1 Disorder. This study will look at the symptoms of bipolar disorder in people who take Ramelteon. The study will enroll approximately 495 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): - Ramelteon (Dose 1) - Ramelteon (Dose 2) - Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient All participants will be asked to take one tablet every night at bedtime throughout the study. This multi-centre trial will be conducted in North America and Europe. The overall time to participate in this study is 13 months. Participants will make 17 visits to the clinic, and will be contacted by telephone 30 days after last dose of study drug for a follow-up assessment. This 12-month study was designed to evaluate the efficacy of TAK-375SL in the maintenance treatment of bipolar 1 disorder. At this time, Takeda has decided to withdraw the study for business reasons. No participants were enrolled in this study. [/INST] To evaluate the efficacy and safety of once a day ramelteon tablets for sublingual administration (TAK-375SL) in the maintenance treatment of bipolar 1 disorder. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - 013[/INST] This is a randomized, placebo-controlled trial of RT001 in patients with PSP. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This study was comprised of participants with severe renal impairment and normal renal function. Participants were residential for a single period of 14 days/13 nights. Participants were discharged from the clinical unit on day 14 on the condition that all required assessments had been performed and that there were no medical reasons for a longer stay in the clinical unit. [/INST] The purpose of the study was to evaluate the pharmacokinetics of a single oral dose of gilteritinib in male and female participants with severe renal impairment compared to healthy male and female participants with normal renal function. This study also evaluated safety and tolerability of a single oral dose of gilteritinib in male and female participants with severe renal impairment and healthy male and female participants with normal renal function. Part 2 of the study (mild and moderate renal impairment) was not conducted based on the final pharmacokinetic findings from part 1 (severe renal impairment). </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III/IV - FLAMINGO - vs. Darunavir/Ritonavir, each with 2 nucleotide background[/INST] This study will be conducted in approximately 468 HIV-1 infected antiretroviral therapy (ART)-naïve subjects. Subjects will be randomized 1:1 to receive dolutegravir (DTG) 50 mg once daily (approximately 234 subjects) or darunavir/ritonavir (DRV/r) 800 mg/100 mg once daily (approximately 234 subjects), each in combination with fixed-dose dual nucleoside reverse transriptase inhibitor (NRTI) therapy (either abacavir/lamivudine (ABC/3TC) or tenofovir/emtricitabine (TDF/FTC). Subjects will be stratified by screening HIV-1 RNA and background NRTI selection. The primary analysis will take place after the last subject completes 48 weeks on therapy; an additional analysis will be conducted after the last subject completes Week 96 on study. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> Subjects were randomized in 1:1 allocation ratio by IWRS according to the stratification factors. However, the control sub-groups (MEC and FLAG) were capped at 100 (50 per sub-group). Subjects in both Arm 1 and Arm 2 were planned to receive induction cycle 1 treatment for at least 14 days. Subjects will receive follow-up therapy based on results of the bone marrow aspirate, and CR/complete remission with incomplete recovery (CRi) status. [/INST] A Phase III study to evaluate the safety and efficacy of CPI-613® (devimistat) in combination with High Dose Cytarabine and Mitoxantrone in comparison with high dose Cytarabine and Mitoxantrone and control sub-groups: combination of Mitoxantrone, Etoposide and Cytarabine (MEC) and combination of Fludarabine, Cytarabine, and Filgrastim (FLAG) in older patients with relapsed/refractory Acute Myeloid Leukemia. CPI-613® (devimistat) targets the altered energy metabolism and processes for production of ATP and essential bio-intermediates unique to and characteristic of most cancer cell types. The addition of CPI-613® (devimistat) to high dose cytarabine and mitoxantrone (CHAM) will improve the complete remission (CR) rate in patients 50 years or older with relapsed or refractory AML when compared to HAM alone or other control sub groups. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> Despite a modest improvement in survival with available chemotherapy treatments, androgen-independent metastatic prostate cancer remains essentially incurable. Several changes in gene function that characterize malignancy have been identified. For example the p53 gene in normal tissue lessens the risk of cancer through growth arrest or cell suicidal programs. Thus the silenced p53 gene present in cancer tissue contributes to the growth of the cancer. In addition when the p53 gene is silenced, a cell survival pathway, controlled by the NF-kB gene, is activated leading increased cell survival. Quinacrine can activate p53 and inhibit NF-kB, thus reestablishing cell suicidal programs and decreasing cell survival in cancer tissue. Moreover, quinacrine is effective against several prostate tumor cell lines in vitro, and has anti-tumor effects against prostate cancer xenografts in mice. [/INST] The purpose of this study is to determine whether quinacrine is effective in the treatment of Androgen-Independent Prostate Cancer. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> Background GD2 is a well-characterized tumor antigen in neuroblastoma, which is also expressed on osteosarcomas and some other sarcomas. T cells expressing 1st generation anti-GD2 chimeric antigen receptors (CARs) were safe and mediated modest antitumor activity in some patients with refractory neuroblastoma. A 3rd generation anti-GD2-CAR (GD2-CAR.OX40.28.z.ICD9) has been produced and holds promise for increased activity compared to the 1st generation GD2-CAR already studied in clinical trials. As an added safety measure, the vector includes a suicide switch comprising a caspase dimerization domain (ICD9) that can be activated by a small molecule to induce death of the genetically engineered cells if they were induce untoward toxicity. Objectives - Primary:Determine the feasibility of producing anti GD2-CAR cells meeting the established release criteria and to assess the safety of administering escalating doses of anti-GD2-CAR engineered T cells in children and young adults with GD2+ solid tumors, including neuroblastoma, following cyclophosphamide-based lymphodepletion. - Seconday: 1) Determine if administration of anti-GD2-CAR engineered T cells mediate antitumor effects in children and young adults with GD2+ solid tumors; 2) Measure persistence of adoptively transferred anti-GD2-CAR T cells and correlate this with antitumor effects; 3) Extend information regarding the prevalence and intensity of GD2 expression in non-neuroblastoma, non- osteosarcoma solid tumors in children and young adults; 4) If unacceptable toxicity occurs that is possibly, probably or likely related to anti-GD2-CAR T cells, assess the capacity for AP1903, a dimerizing agent, to mediate clearance of the genetically engineered cells and resolve toxicity; and 5) Assess toxicity of AP1903 if administered to mediate clearance of anti-GD2-CAR T cells. Eligibility Patients 1-35 years of age, at least 15 kg, with osteosarcoma or a GD2+ solid tumor (including neuroblastoma) that has recurred after or not responded to standard therapy and is deemed incurable by standard therapy. Design After apheresis to collect T cells for transduction, patients receive cyclophosphamide 1800mg/m(2)/d as a lymphodepleting regimen. A phase I cell dose escalation scheme will used at 4 dose levels (1 x 10(5) transduced T cells/kg; 1 x 10(6) transduced T cells/kg; 3 x 10(6) transduced T cells/kg; and 1 x 10(7) transduced T cells/kg), using a standard 3 plus 3 dose escalation design. An expanded group of a total of 12 patients will be treated at the highest dose, comprising at least 6 osteosarcoma patients. Patients will be monitored for toxicity, antitumor effects and persistence of anti-GD2-CAR T cells. Patients with a PR, SD may receive a 2nd cycle at the next higher dose level a minimum of 60 days following completion of the first cycle if eligibility criteria are met. A maximum of 36 patients may be treated on this study. Given that there is likelihood that some patients with non-osteosarcoma will not meet the criteria for GD2 expression to be eligible for enrollment, up to 72 subjects will be screened to enroll a maximum of 36 patients for treatment. Up to 2-3 patients will be accrued per month, and therefore this study may require up to 2-3 years to complete enrollment and treatment. [/INST] Background GD2 is a well-characterized tumor antigen in neuroblastoma, which is also expressed on osteosarcomas and some other sarcomas. T cells expressing 1st generation anti-GD2 chimeric antigen receptors (CARs) were safe and mediated modest antitumor activity in some patients with refractory neuroblastoma. A 3rd generation anti-GD2-CAR (GD2-CAR.OX40.28.z.ICD9) has been produced and holds promise for increased activity compared to the 1st generation GD2-CAR already studied in clinical trials. As an added safety measure, the vector includes a suicide switch comprising a caspase dimerization domain (ICD9) that can be activated by a small molecule to induce death of the genetically engineered cells if they were induce untoward toxicity. Objectives Primary:Determine the feasibility of producing anti GD2-CAR cells meeting the established release criteria and to assess the safety of administering escalating doses of anti-GD2-CAR engineered T cells in children and young adults with GD2+ solid tumors, including neuroblastoma, following cyclophosphamide-based lymphodepletion. Secondary: 1. Determine if administration anti-GD2-CAR engineered T cells mediate antitumor effects in children and young adults with GD2+ solid tumors; 2. Measure persistence of adoptively transferred anti-GD2-CAR T cells and correlate this with antitumor effects; 3. Extend information regarding the prevalence and intensity of GD2 expression in non-neuroblastoma, non-osteosarcoma solid tumors in children and young adults; 4. If unacceptable toxicity occurs that is possibly, probably or likely related to anti-GD2-CAR T cells, assess the capacity for AP1903, a dimerizing agent, to mediate clearance of the genetically engineered cells and resolve toxicity; and 5. Assess toxicity of AP1903 if administered to mediate clearance of anti-GD2-CAR T cells. Eligibility Patients 1-35 years of age, at least 15 kg, with osteosarcoma or a GD2+ solid tumor (including neuroblastoma) that has recurred after or not responded to standard therapy and is deemed incurable by standard therapy. Design After apheresis to collect T cells for transduction, patients receive cyclophosphamide 1800mg/m(2)/d as a lymphodepleting regimen. A phase I cell dose escalation scheme will used at 4 dose levels (1 x 10(5) transduced T cells/kg; 1 x 10(6) transduced T cells/kg; 3 x 10(6) transduced T cells/kg; and 1 x 10(7) transduced T cells/kg), using a standard 3 plus 3 dose escalation design. An expanded group of a total of 12 patients will be treated at the highest dose, comprising at least 6 osteosarcoma patients. Patients will be monitored for toxicity, antitumor effects and persistence of anti-GD2-CAR T cells. Patients with a PR, SD may receive a 2nd cycle at the next higher dose level a minimum of 60 days following completion of the first cycle if eligibility criteria are met. A maximum of 36 patients may be treated on this study. Given that there is likelihood that some patients with non-osteosarcoma will not meet the criteria for GD2 expression to be eligible for enrollment, up to 72 subjects will be screened to enroll a maximum of 36 patients for treatment. Up to 2-3 patients will be accrued per month, and therefore this study may require up to 2-3 years to complete enrollment and treatment. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - V1.4 (China)[/INST] The primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of single-dose, dose-escalated, abdominal subcutaneous injection of GB224 in Chinese healthy adult subjects. The secondary objectives are to preliminarily understand the immunogenicity and pharmacodynamic variable (IL-6) of single abdominal subcutaneous injection of GB224 in Chinese healthy adult subjects. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase IIa - Dose Escalation[/INST] The objectives of this study are to assess the safety, effectiveness, and immunogenicity of AA4500 in the treatment of adhesive capsulitis. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This was a multicenter, randomized, double-blind, parallel group, active-controlled, study to evaluate the efficacy and safety of sacubitril/valsartan compared to valsartan, on morbidity and mortality in heart failure patients (NYHA Class II-IV) with preserved ejection fraction. Specifically, the study evaluated the effect of sacubitril/valsartan compared to the active comparator valsartan in the reduction of the rate of CV death and total HF hospitalizations in patients with HFpEF. The trial consisted of two periods: (1) a single-blind treatment run-in epoch that lasted from 3 to 8 weeks, in which patients received valsartan 80 mg bid, followed by sacubitril/valsartan 100 mg bid and (2) a double-blind randomized treatment epoch (sacubitril/valsartan 200 mg bid or valsartan 160 mg bid). In this study, investigators were responsible for assessing and submitting all events which could potentially fulfill the criteria for the primary, secondary, or other clinical endpoints to a Clinical Endpoint Committee (CEC). Investigator reported events were assessed by the CEC for adjudication. For angioedema or angioedema-like events, investigators completed an Adjudication Questionnaire for an Angioedema-like Event form. All angioedema reports were forwarded to an Angioedema Adjudication Committee (AAC) by Novartis for assessment. [/INST] The purpose of this study was to evaluate the effect of LCZ696 compared to valsartan in the reduction of cardiovascular death and heart failure(HF) hospitalizations in patients with HF with preserved ejection fraction. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This is a randomized, double-blind, placebo-controlled, Phase 2 trial to evaluate QPI-1002 versus placebo for the prevention of AKI in subjects who are at high risk for AKI following cardiac surgery. [/INST] This trial is designed to evaluate QPI-1002 versus placebo for the prevention of AKI in subjects who are at high risk for AKI following cardiac surgery. Half of the participants will receive QPI-1002 while the other half will receive placebo. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This study will evaluate AXS-05 in a randomized, double-blind, placebo-controlled study in patients with MDD. Eligible patients will be randomized in a 1:1 ratio to treatment with AXS-05 or placebo for 6 weeks. [/INST] A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD). </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I/II - BMX-HGG[/INST] This is a Phase 2 study of newly diagnosed patients with high grade glioma (HGG) undergoing standard radiation therapy and temozolomide treatment. BMX-001 added to radiation therapy and temozolomide has the potential not only to benefit the survival of high grade glioma patients but also to protect against deterioration of cognition and impairment of quality of life. BMX-001 will be given subcutaneously first with a loading dose zero to four days prior to the start of chemoradiation and followed by twice a week doses at one-half of the loading dose for the duration of radiation therapy plus two weeks. Both safety and efficacy of BMX-001 will be evaluated. Impact on cognition will also be assessed. Eighty patients will be randomized to the treatment arm that will receive BMX-001 while undergoing chemoradiation and 80 patients randomized to receive chemoradiation alone. The sponsor hypothesizes that BMX-001 when added to standard radiation therapy and temozolomide will be safe at pharmacologically relevant doses in patients with newly diagnosed high grade glioma. The sponsor also hypothesizes that the addition of BMX-001 will positively impact the overall survival and improve objective measures of cognition in newly diagnosed high grade glioma patients. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase IIIb - BEGIN-SWITCH 1[/INST] This trial is conducted in Europe and the United States of America (USA). The aim of the trial is to compare the safety and efficacy of insulin degludec (IDeg) and insulin glargine (IGlar), both with insulin aspart (IAsp) as mealtime insulin in subjects with type 1 diabetes. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - P06203[/INST] This study of the safety, tolerability, and efficacy of MK-8353 (formerly SCH 900353) given as single agent oral therapy for participants with advanced solid tumors will be done into two parts. In Part 1a, there will be a dose escalation to find the preliminary maximum tolerated dose (MTD), and in Part 1b, dose confirmation to find out the recommended Phase 2 dose (RPTD) that will be used in Part 2 of the study. In Part 2 of the study, participants with certain types of metastatic melanoma or metastatic colorectal cancer will be treated to see if MK-8353 is effective as single agent therapy. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - First-In-Human[/INST] Evaluate the safety and tolerability of AMG 427 in adult subjects with relapsed/refractory AML. Estimate the maximum tolerated dose (MTD) and / or a biologically optimal dose (eg, recommended phase 2 dose [RP2D]). </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> A decision was made to switch all patients on fingolimod 1.25 mg/day to fingolimod 0.5 mg/day in an amendment to the study protocol. The study became open-label with all patients receiving fingolimod 0.5 mg/day on 22 Feb 2010. The efficacy data for Months 0-6 in this study report is from the core study NCT00537082. [/INST] This study was an extension study of NCT00537082. This study was designed to evaluate the efficacy and safety of long-term administration of 0.5 mg or 1.25 mg of fingolimod (FTY720) to relapsing multiple sclerosis. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - Dose Escalation/Expansion[/INST] This is a first-in-human, open-label, nonrandomized, four-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX-105 and INBRX-105 in combination with Pembrolizumab. INBRX-105, a next generation bispecific antibody, targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor. INBRX-105 provides localized conditional T-cell co-stimulation through 4-1BB agonism. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> PRIMARY OBJECTIVES: I. To determine if the 48-hour trough serum asparaginase activity is ? 0.1 IU/mL in young patients with acute lymphoblastic leukemia treated with Erwinia asparaginase after allergy to PEG-asparaginase. II. To determine the frequency of asparaginase-related toxicity in these patients. III. To characterize the pharmacokinetics of Erwinia asparaginase in these patients. SECONDARY OBJECTIVES: I. To compare serum asparaginase activity and serum asparagine concentration between patients treated with Erwinia asparaginase on this trial and historical controls treated with PEG-asparaginase on CCG-1961 and CCG-1962. II. To determine the 72-hour serum asparaginase activity on days 8 or 11 or 13 based on the starting date of Erwinia asparaginase therapy. III. To determine the presence of anti-Erwinia asparaginase antibodies in patients treated with a course(s) of Erwinia asparaginase following clinical allergy to PEG-asparaginase (PEG, pegaspargase). IV. To determine if serum asparagine is adequately depleted on days 12 or 13 in a subset of these patients. OUTLINE: This is a multicenter study. Patients receive 6 doses of Erwinia asparaginase intramuscularly (IM) on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol. Blood samples are collected periodically for pharmacokinetic, pharmacodynamic, and antibody studies. After completion of study treatment, patients are followed periodically. [/INST] This clinical trial is studying the side effects of Erwinia asparaginase and what happens to the drug in the body in treating young patients with acute lymphoblastic leukemia who are allergic to PEG-asparaginase. Drugs used in chemotherapy, such as Erwinia asparaginase, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - Acute Organ Failure[/INST] Evaluate safety and efficacy of DUR-928 in treatment of acute organ failure in subjects infected with SARS-CoV-2 </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - Alternative Dosing[/INST] The purpose of this study was to evaluate the effect of an alternative dosing strategy of ruxolitinib in subjects with primary myelofibrosis (PMF), post-polycythemia vera-myelofibrosis (PPV-MF) and post essential thrombocythemia-myelofibrosis (PET-MF) in order to minimize the development of anemia and thrombocytopenia. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - 2101 (HER2-)[/INST] The purpose of this study is to compare the effects, good and/or bad, of standard of care therapy (docetaxel or paclitaxel) with or without the addition of 1-Methyl-D-tryptophan (referred to as indoximod) an experimental drug to find out which treatment is better. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> The outcome measures are planned to be assessed up to the data cutoff date. Following the data cutoff date, the participants will either stay on the study and will be followed for safety data collection or rolled into another Gilead-sponsored study. Therefore, only safety data will be collected after the data cutoff date. [/INST] The primary objective in Phase I is to evaluate the safety and tolerability of sacituzumab govitecan-hziy (SG) as a single agent administered in 21-day treatment cycles in previously treated participants with advanced epithelial cancer. In Phase II, the primary objective is to evaluate the safety and efficacy of sacituzumab govitecan-hziy administered in 21-day treatment cycles at a dose selected in Phase I. Tumor types in the study will include: cervical, colorectal, endometrial, ovarian, esophageal, gastric adenocarcinoma, glioblastoma multiforme, head and neck cancers- squamous cell, hepatocellular, prostate, non-small-cell lung cancer, pancreatic, renal cell, small-cell lung cancer, non-triple negative breast cancer (non-TNBC), triple-negative breast cancer (TNBC) and metastatic urothelial cancer (mUC). </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - ASSENT (U.S.)[/INST] The primary objective of the trial is the confirmation of the efficacy of AM-111 in the recovery of severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL). </s>