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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 - Parkinson[/INST] Gastric emptying is the end-result of a complex and carefully regulated series of events which follow the ingestion of a meal, each of which is dependent on the other and subject to neurohormonal control. Motilin is an endogenous peptide, produced mainly in the duodenum, whose physiological action is mediated by motilin receptors located on enteric neurons, peripheral terminals of the vagus, and on the smooth muscle of the gut. Motilin and non-peptide agonists at motilin receptors increases the gastric emptying rate and therefore provide a potential approach to the treatment of a range of clinical conditions in which delayed gastric emptying is thought to be part of the physiopathology and may be contributory to symptoms. Parkinson's disease (PD) is a progressive neurodegenerative disorder characterized by degeneration of nigrostriatal dopaminergic neurones. It affects 1.5% of the global population over 65 years of age. Cardinal symptoms comprise bradykinesia, rigidity, resting tremors and postural instability. Gastrointestinal dysfunction, including gastroparesis, is a frequent feature of PD affecting approximately 90% of patients, and is caused by autonomic dysfunction as well as an adverse effect of antiparkinsonian drug therapy. The therapeutic mainstay for PD treatment is the neutral amino acid L-3,4-dihydroxyphenylalanine (L-DOPA), a dopamine prodrug, as it provides the most rapid and effective symptomatic control of motor impairment in PD. The primary determinant of L-DOPA bioavailability is gastric emptying (GE); delays in GE slow delivery of L-DOPA to its proximal small intestinal absorption sites, increasing the extent of presystemic metabolism, and leading to slowed and diminished absorption. </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/III - ABS-AS-301[/INST] The study will measure the change in lung function in subjects with asthma after inhaling from either of two inhalers: Albuterol Spiromax® or placebo. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This study will be conducted in approximately 36 sites in Asian countries. Approximately 1004 subjects will be screened and 342 randomized. Prior to the screening, subjects of Stratum A should have a stable dose of metformin (≥1500 mg/day or a maximal tolerated dose) for at least 8 weeks. And subjects of Stratum B should have a stable dose of metformin (≥1500 mg/day or a maximal tolerated dose) AND a dipeptidyl peptidase-4 inhibitor at maximum approved dose for at least 8 weeks prior to the screening. Eligible subjects who complete the screening visit will enter the lead-in period, which includes open-label saxagliptin 5 mg and metformin treatment for 16 weeks in Stratum A or 8 weeks in Stratum B. At randomization visit, eligible subjects will be randomized into 1 of 3 treatment groups in a 1:1:1 ratio, receiving blinded dapagliflozin 5 mg, 10 mg or placebo plus metformin and saxagliptin 5 mg treatment for 24 weeks. [/INST] This is a 24-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel group, phase 3 study designed to evaluate if the safety and efficacy of dapagliflozin 5 mg or 10 mg added to saxagliptin 5 mg plus metformin is superior to placebo added to saxagliptin 5 mg plus metformin in reducing hemoglobin A1c (HbA1c). </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> Secondary hyperparathyroidism (SHPT) is a condition that can develop early in patients with chronic kidney disease (CKD), usually gets worse over time, and is known to cause problems for patients on dialysis. Children on dialysis can have a wide range of bone and growth issues, and common treatments have a chance of making these things worse by increasing serum calcium and serum phosphorus. Cinacalcet has been shown to be effective in controlling parathyroid hormone (PTH), calcium and phosphorus in adults. The purpose of this study is to show that including cinacalcet in the treatment of SHPT will lower the levels of intact parathyroid hormone (iPTH) in a larger number of pediatric patients with CKD who are receiving dialysis, compared to a treatment regimen that does not include cinacalcet. [/INST] The purpose of this study is to assess the safety and efficacy of adding cinacalcet to the current treatment of secondary hyperparathyroidism in children currently receiving dialysis compared to a treatment regimen that does not include cinacalcet. </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 - Tulip SC[/INST] The purpose of this study is evaluating the efficacy and safety of SC antifrolumab in adult patients with moderate -to-severe SLE despite receiving standard 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 II - TheraP[/INST] This open label, randomised, stratified, 2-arm, multicentre, phase 2 trial aims to determine the activity and safety of Lu-PSMA vs cabazitaxel in men with progressive metastatic castration resistant prostate cancer </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> The study will be conducted in the following parts: Part A: Intravenous (IV) monotherapy dose-regimen finding for solid tumors -- Dose-escalation, and possible dose-interval modification to lengthen the treatment cycle, to define the IV SEA-CD40 monotherapy maximum tolerated dose (MTD) and/or the optimal biological dose (OBD) regimens in patients with solid tumors. The ability to increase the dose intensity (to give additional doses within a treatment cycle) may be evaluated. Part B: IV monotherapy solid tumor expansion cohorts -- Disease-specific solid tumor expansion cohorts may be enrolled where patients will be treated with doses at or below the IV SEA-CD40 monotherapy MTD and/or OBD determined in Part A. Part C: IV monotherapy dose-regimen finding for lymphomas -- Dose-escalation, and possible dose-interval modification to lengthen the treatment cycle, to define the IV SEA-CD40 monotherapy MTD and/or the OBD regimens in patients with lymphomas. The ability to increase the dose intensity (to give additional doses within a treatment cycle) may be evaluated. Part D: IV monotherapy lymphoma expansion cohorts -- Disease-specific lymphoma expansion cohorts may be enrolled where patients will be treated with doses at or below the IV SEA-CD40 monotherapy MTD and/or OBD determined in Part C. Part E: Combination therapy dose-regimen finding for solid tumors -- IV SEA-CD40 dose-escalation to define the MTD and/or the OBD regimen to be administered in combination with standard approved dose of pembrolizumab in patients with solid tumors. Part F: Combination therapy solid tumor expansion cohorts -- Disease-specific solid tumor expansion cohorts may be enrolled where patients will be treated with IV SEA-CD40 and pembrolizumab combination therapy; doses of SEA-CD40 will be at or below the MTD and/or OBD determined in Part E. Part G: Subcutaneous (SC) injection (injected under the skin) monotherapy dose-regimen finding for solid tumors -- Dose-escalation, and possible dose-interval modification to lengthen the treatment cycle, to define the SC SEA-CD40 monotherapy maximum tolerated dose (MTD) and/or the optimal biological dose (OBD) regimens in patients with solid tumors. Part H: SC monotherapy solid tumor expansion cohorts -- Disease-specific solid tumor expansion cohorts may be enrolled where patients will be treated with doses at or below the SC SEA-CD40 monotherapy MTD and/or OBD determined in Part G. (Note: There is no Part I) Part J: SC monotherapy dose-regimen finding for lymphomas -- Dose-escalation, and possible dose-interval modification to lengthen the treatment cycle, to define the SC SEA-CD40 monotherapy MTD and/or the OBD regimens in patients with lymphomas. Part K: SC monotherapy lymphoma expansion cohorts -- Disease-specific lymphoma expansion cohorts may be enrolled where patients will be treated with doses at or below the SC SEA-CD40 monotherapy MTD and/or OBD determined in Part J. Part L: Combination therapy in pancreatic cancer -- Patients will be treated with SEA-CD40 doses at or below MTD and/or OBD. An established dose of pembrolizumab and a standard regimen of gemcitabine and nab-paclitaxel will be used. In Parts A, C, E, G, and J, a maximum feasible dose (MFD) will be defined if an MTD and/or OBD cannot be identified. Parts B, D, F, H, K. and L will explore the recommended dosing regimen once the MTD and/or OBD, or MFD (if the MTD and/or OBD cannot be identified) has been determined. [/INST] This study is being done to find out if SEA-CD40 is safe and effective when given alone, in combination with pembrolizumab, and in combination with pembrolizumab, gemcitabine, and nab-paclitaxel. The study will test increasing doses of SEA-CD40 given at least every 3 weeks to small groups of patients. The goal is to find the highest dose of SEA-CD40 that can be given to patients that does not cause unacceptable side effects. Different dose regimens will be evaluated. Different methods of administration may be evaluated. The pharmacokinetics, pharmacodynamic effects, biomarkers of response, and antitumor activity of SEA-CD40 will also be evaluated. </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 - PREVAIL OLE (Extension)[/INST] The purpose of this study is to examine the safety of USL255 as adjunctive therapy in patients with refractory partial onset-seizures. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This was a double-blind, randomised, vehicle-controlled, parallel group study in males and females, aged three years and older with active head lice infestation. The study was designed to assess the ovicidal efficacy 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 the study site. This study used an ex vivo method of assessment for ovicidal efficacy. [/INST] The purpose of the study was to evaluate ovicidal efficacy of a single application of abametapir lotion 0.74% w/w intended for the treatment of head lice. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This trial consists of two parallel arms. For each treatment arm, a 3+3 dose escalation design will be applied in 3-6 subject cohorts until the maximum tolerated dose of IPI-145 when given with rituximab (Arm 1) or in combination with rituximab and bendamustine (Arm 2) is determined. Treatment arm selection will be chosen by the investigator and will depend on the agents previously administered to the subject. Once the MTD has been determined, the arms will move on to a dose expansion phase. During the dose expansion phase, each treatment arm will enroll to population specific cohorts to assess efficacy. All subjects must have had at least one prior anticancer treatment. The dose expansion cohorts are: Arm 1: Cohort A - CLL: Cohort B - CD20+ NHL Arm 2: Cohort A - CLL: Cohort B - CD20+ NHL [/INST] The goal of this study is to characterize the safety, maximum tolerated dose (MTD) and preliminary efficacy profile of IPI-145 given in combination with rituximab, or bendamustine plus rituximab, to subjects with select relapsed/refractory hematologic malignancies. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> Eligible patients will be treated with 4 µg GAD-Alum into an inguinal lymph gland at three occasions, with one month intervals in combination with Vitamin D (14 000 IU/week) for 4 months, starting 1 month prior to first GAD-Alum injection. A sub-study will include three adult patients from the main study and evaluate safety after a fourth injection with 4 μg GAD-Alum into an inguinal lymph gland in combination with oral vitamin D intake. The Prolonged Extension Study Period is 12 months and will start 30,5 months after baseline. [/INST] The objectives of the main study is to: - Evaluate the safety of giving GAD-Alum (Glutamic acid decarboxylase) (Diamyd) directly into lymph glands in combination with an oral vitamin D regimen - Evaluate how the above mentioned treatments influence the immune system and endogenous insulin secretion. The objective of the sub-study is to: - Evaluate safety after a fourth injection with 4 μg GAD-Alum direct into an inguinal lymph gland in 3 adult patients from the main study - Evaluate how the above mentioned treatment influences the immune system and endogenous insulin secretion. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> The sponsor of the current study is now Acrotech Biopharma, divested from Spectrum Pharmaceuticals Inc. (Spectrum), which licensed the Melphalan HC1 for Injection (Propylene Glycol-Free) product from Ligand Pharmaceuticals , formerly CyDex Pharmaceuticals, Inc. (CyDex). This new injectable form of melphalan HCL incorporates Captisol®, β cyclodextrin sulfobutyl ether sodium salts (also known as [SBE]7m-β-CD), into the product. Captisol is present to facilitate the use of an all aqueous diluent (normal saline) for reconstitution and administration of the freeze-dried product in place of the propylene glycol-ethanol diluent necessary for the currently used melphalan intravenous product. Captisol provides for solubilization and improved stability of the all aqueous reconstituted and diluted infusion solution. This is the second of two studies supporting product registration. This study will be a multicenter study of high-dose Melphalan HCL for Injection (Propylene Glycol-Free) conducted in 60 patients who have symptomatic MM and qualify for autologous stem cell transplantation (ASCT). During the Study Period, patients will receive 100mg/m2 of either Melphalan HCL for Injection (Propylene Glycol-Free) on Day -3 and on Day -2 for a total dose of 200mg/m2. Blood samples (5 timepoints post infusion) for population pharmacokinetic (PK) evaluation will be withdrawn through an indwelling i.v. cannula on the first day of administration of melphalan (Day -3) for all patients and then additional blood samples (2 timepoints post infusion) drawn in a subset of patients on the second day of melphalan administration (Day -2). Following one day of rest after the high dose myeloablative conditioning (Day -1), patients will receive an autologous graft (Day 0). [/INST] The purpose of this trial is to confirm the safety and efficacy of high-dose Melphalan HCL for Injection (Propylene Glycol-Free) as a myeloablative conditioning regimen in multiple myeloma patients (MM) undergoing autologous transplantation. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This was a Phase 3 open-label, non-randomized, multicenter study of the safety, tolerability, and efficacy of oral brincidofovir (BCV) when administered twice weekly for the treatment of disseminated adenovirus (AdV) disease and for the treatment of AdV infection when treatment was initiated in subjects who were at risk of progression to disseminated disease (i.e., during the asymptomatic or localized phases of infection). [/INST] This was a Phase 3 open-label, non-randomized, multicenter study of oral brincidofovir (BCV) administered twice weekly for the treatment of adenovirus (AdV) infection detected during asymptomatic AdV viremia or during symptomatic AdV infection. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This is a first-in-human (FIH), Phase 1, open-label, multicenter and 2-part study. The Part 1 of study will be Dose Escalation phase to determine the recommended Phase 2 dose (RP2D) based on safety and pharmacodynamic assessments and Part 2 will be Dose Expansion Phase to evaluate 2 expansion cohorts (Cohort 2A and 2B) after the RP2D for JNJ-64041809 is determined in Part 1. The study will consist of a Screening Period (from signing of informed consent until immediately before the first dose), an open-label Treatment Period (from the first dose of study drug until the End-of-Treatment Visit); and a Post treatment Follow-up Period (after the End-of Treatment Visit until study discontinuation). Participants will be primarily evaluated for RP2D. Participants safety will be evaluated throughout the study. [/INST] The purpose of this study is to find and evaluate the recommended Phase 2 dose (RP2D) of JNJ-64041809, a live attenuated double deleted (LADD) Listeria monocytogenes (bacteria in which two virulence genes, which encode molecules that help cause disease, have been removed) when administered intravenously to participants with metastatic castration-resistant prostate cancer (mCRPC). </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This was a phase 2a multicenter, open-label, sequential, 3-arm, combination treatment study of a regimen of ABT-450/r/ABT-333, and ribavirin (RBV) in hepatitis C virus (HCV) genotype 1-infected treatment-naïve participants and previous non-responders to pegylated interferon (pegIFN)/RBV treatment. [/INST] The purpose of this study is to evaluate the antiviral activity, safety, and pharmacokinetics of ABT-450 with ritonavir (ABT-450/r) dosed in combination with ABT-333 (also known as dasabuvir) and ribavirin (RBV) in treatment-naïve and non responder participants with genotype 1 chronic hepatitis C virus (HCV) infection. </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 - 1st Line vs. Gleevec[/INST] Masitinib in First Line Treatment of Gastro-Intestinal Stromal Tumor (GIST) </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 - 005[/INST] This study will evaluate the safety, tolerability, and PK of MK-8892 in participants with pulmonary arterial hypertension. The primary hypothesis is that the geometric mean of MK-8892 area under the concentration time-curve from Hour 0 to 24 hours (AUC0-24hr) in participants with PAH, will be equal to or greater than the efficacious exposure in humans of 0.6 μM•hr. </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 - Study 201 (Bacterial Vaginosis)[/INST] The purpose of this research study is to test the safety and effectiveness of the oral investigational new drug, SYM-1219, for the treatment of bacterial vaginosis. </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 - Extension Study (ARIDO)[/INST] This is an open-label, long-term safety study of glycopyrronium topical wipes, enrolling up to 660 subjects with primary axillary hyperhidrosis who participated in either the DRM04-HH04 or DRM04-HH05 studies. </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 - Proof-of-Concept (w/Levodopa)[/INST] This study assesses the safety, tolerability, pharmacokinetics and efficacy of SAGE-217 in 29 participants with moderate to severe Parkinson's Disease. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> The Part A of the study is currently not accepting healthy volunteers as the recruitment for the part A has completed. [/INST] The purpose of this study is to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of M254 after administration of a single ascending dose and repeat doses in healthy volunteers and immune thrombocytopenic purpura (ITP) patients. The pharmacodynamics of the drug will be measured as platelet response in patients with ITP. </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 - Safety/Immunogenicity[/INST] This is a randomized, observer-blinded, placebo-controlled trial in adults ≥18 years old. Randomization will be stratified by age (18 to 49 years and ≥50 years) and by prior influenza immunization within the past three months. Proportions of subjects in the various strata will not be pre-specified; rather, the goal will be to achieve an approximately equal distribution of subjects with these characteristics across the various treatment groups. Treatments will comprise two identical IM doses at a 21-day interval (Day 0 and Day 21), in alternate deltoids. For each subject, study follow-up will span approximately 385 days total, or approximately 13 months from the first dose. </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 patients with renal cancer treated with cabozantinib (cabozantinib-s-malate) will have improved progression-free survival compared to patients treated with sunitinib (sunitinib malate). SECONDARY OBJECTIVES: I. To determine whether the response rate of patients with renal cancer treated with cabozantinib will be higher when compared with patients treated with sunitinib. II. To determine whether patients with renal cancer treated with cabozantinib will have an improved overall survival when compared with patients treated with sunitinib. TERTIARY OBJECTIVES: I. To determine whether renal cancer patients with high MET expression by immunohistochemistry (IHC) have improvement in progression-free survival compared to patients with low MET expression on both arms of this study. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive cabozantinib-s-malate orally (PO) once daily (QD) for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 5 years. [/INST] This randomized phase II trial studies how well cabozantinib-s-malate works compared to sunitinib malate in treating patients with previously untreated kidney cancer that has spread from where it started to nearby tissue or lymph nodes or to other places in the body. Cabozantinib-s-malate and sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether cabozantinib-s-malate is more effective than sunitinib malate in treating patients with kidney 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 II - CELEST[/INST] To determine the efficacy and safety of multiple doses of ABT-494 in subjects with moderately to severely active Crohn's Disease with a history of inadequate response to or intolerance to Immunomodulators or anti-Tumor Necrosis Factor (TNF) 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 III - Children/Adolescents (EU) (SPD489-325)[/INST] The main aim of this study is to see if giving LDX to children and adolescents aged 6-17 years with ADHD decreases symptoms of ADHD. </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 - Plaque Psoriasis (Germany - 203820)[/INST] GSK2981278 is an inverse agonist of retinoic acid receptor-related orphan receptor (ROR) gamma. The aim of this study is to evaluate the safety, tolerability, clinical effect, and systemic exposure potential of topically applied GSK2981278 ointment in subjects with plaque psoriasis by treating all plaques on the body for 8 weeks. This single-center study will be conducted in two parts. Part A will be an open-label, single arm study and part B will be a double-blind, randomized, 2-arm, parallel-group, vehicle-controlled study. In Part A, 8 adult subjects and in Part B, 18 adult subjects with chronic stable plaque psoriasis will be enrolled. Total duration of study will be approximately 14 weeks. The results of this study will provide preliminary information about safety and efficacy of the drug and will help in providing the guidance for further development strategy. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This is a multicenter, double blind, randomized trial examining combination therapy versus single agent therapy with three-year follow-up on the last patient randomized. All patients will remain on therapy until the last patient completes the study. All patients will then be transitioned, based on the findings, to open label of combination with continued follow-up or some recommendation about single agent therapy. While the study design benefits from having two arms of single agent therapy to examine the important question of whether there are differences between the single agents, the primary interest is in combination therapy. Therefore, a two-group combination versus single agent concept was used - splitting the population into single agent and combination therapy equally. The single agent arm is divided into two groups, IFN and GA providing for 3 treatment arms: IFN intramuscularly (IM) and GA subcutaneously (SC) (50% of the patients), IFN IM and placebo SC (25% of the patients) and GA SC and placebo IM (25% of the patients). [/INST] This is for a randomized clinical trial (RCT) to determine if the combined use of interferon beta-1a (IFN) and glatiramer acetate (GA) is a measurably better therapy than either agent used individually in patients with relapsing-remitting (RR) multiple sclerosis (MS). </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 - Post-HERCULES[/INST] The objectives of this study were to evaluate long-term safety and efficacy of caplacizumab, to evaluate safety and efficacy of repeated use of caplacizumab and to characterize long-term impact of acquired thrombotic thrombocytopenic purpura (aTTP). </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 - ORION-16[/INST] This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in adolescents with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDL-C). </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 - JAB-8263-1001[/INST] This is a Phase 1, first-in-human, open-label study of JAB-8263 to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) and assess the DLT. 30 subjects with advanced solid tumor will be enrolled. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This open-label, multicenter, randomized study will consist of 2 phases: - Phase Ib: a safety run-in period with 3 ascending doses of eribulin; - Phase II: a randomized 2-arm design. Phase Ib Patients will be recruited into cohorts, with a minimum of 3 and a maximum of 6 patients per cohort. All patients will receive the same dose of gemcitabine (1000 mg/m2 on Days 1 and 8 of a 21-day cycle) and cisplatin (70 mg/m2 on Day 1) in combination with eribulin (administered on Days 1 and 8 of the cycle). All patients in a cohort will receive the same dose level of eribulin. The dose level of eribulin will be escalated for additional cohorts unless greater than 2 dose limiting toxicities (DLTs) are reported at the lower dose level(s) prior to enrollment of the next dose level. If one DLT occurs at any dose level, the cohort will be expanded to include up to a maximum of 6 patients. A Dose Escalation Committee will determine when no further dose escalation is appropriate and whether the MTD will be defined as a preceding dose or an intermediate dose. Phase II Patients will be randomized in a 1:1 ratio to receive either eribulin in combination with gemcitabine plus cisplatin (Arm 1) or gemcitabine plus cisplatin alone (Arm 2). The eribulin dose will be 1.0 mg/m2 administered on Days 1 and 8 of each 21-day treatment cycle, the recommended Phase II dose for eribulin when administered in combination gemcitabine plus cisplatin, as determined in the Phase Ib portion of the study. Allocation of patients will be stratified based on metastatic disease status (patients with visceral metastases versus patients with non-visceral metastases). This stratified randomization will be centrally allocated across all centers via an Interactive Voice Activated Response System (IVRS). For both the Phase Ib and Phase II portions, 1 cycle of therapy will last 21 days, with a maximum number of 6 gemcitabine plus cisplatin cycles. Radiologic examinations including a computed tomography (CT) scan of the chest, abdomen, and pelvis as appropriate (and CT or magnetic resonance imaging [MRI] scan as appropriate), will be performed during Screening and after every 6 weeks while on therapy. In the case of dose delays, scans should be performed according to the original Cycle 1 Day 1 schedule (ie, scans should not be delayed). Radiographic assessments should be repeated at withdrawal if the last assessment was obtained greater than 3 weeks from withdrawal of therapy. Patients will be followed until death following completion of therapy. Scans will be required every 2 months until documentation of PD or the start of a next line of therapy, whichever occurs first. In patients experiencing PD, follow-up will be for survival only and radiographic scans are not required. [/INST] The purpose of this study is to determine whether Patients with Locally Advanced or Metastatic Bladder Cancer who receive Eribulin Mesylate Administered in Combination with Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin Alone as First-Line Therapy is safety and tolerable when administered to patients with locally advanced or metastatic bladder cancer and to gain preliminary data on whether patients may benefit from this combination. </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 - BMX-DERM-01[/INST] This is a randomized, placebo-controlled Phase 2 trial consisting of up to 300 subjects with either psoriasis or atopic dermatitis. In this trial BMX-010 will be topically applied twice daily for up to 28 days. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase IV - COMPASS-3[/INST] An open label, non-comparative study design is appropriate for this Phase 4 study designed to assess whether a core therapy of bosentan, either as monotherapy or with the addition of sildenafil, enables patients with pulmonary arterial hypertension (PAH) to achieve a 6-minute walk distance (6 MWD) of ≥380 meters after 28 weeks of therapy This design is also appropriate to pioneer the utility of cardiac MRI in assessing improved functional capacity in PAH and exploring its correlation with other parameters. </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 - APPLAUD[/INST] An International Phase II, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of LAU-7b administered once-daily for 6 months for the treatment of CF. </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 - SRT-2104-011[/INST] Randomized, placebo-controlled, parallel-group, double-blind, multiple-dose, activity and safety clinical study of SRT2104 administered orally once daily for 28 consecutive days. This will be an inpatient/outpatient study to assess the safety and pharmacokinetics of SRT2104 in type 2 diabetic male and female subjects on an existing, stable, background metformin therapy. Approximately 80 subjects will be enrolled. Subjects will be evenly randomized to receive SRT2104 2.0 g/day or placebo in the fed state. Subjects will be required to stay overnight at the study center on Days -2, -1, 0, 1 (optional discharge at investigator's discretion), 27, 28, 41, and 42. During these admissions, pharmacokinetic, biomarker and glycated albumin samples will be collected, and glucose profiling, OGTT, glucose stabilization, hyperinsulinemc euglycemic clamp (HEGC) studies with indirect calorimetry and various other safety and activity procedures will be performed. On Day 1 of the study, subjects will be randomized to receive SRT2104 or placebo. Day 43 will be the last day of the study and subjects will be released. In addition, subjects will be asked to return to the study center on Day 14 for interim safety assessments. During the dosing period, study personnel will contact subjects by telephone on Days 7 and 21 to conduct a safety assessment. Subjects will be required to monitor their fasting blood glucose and complete a daily diary for the outpatient portion of the study between Days 1 and 28. A follow-up, safety phone call will occur 30 days following their final dose of SRT2104 or placebo (Day 58 of the study) to identify any possible additional adverse events or concomitant medications. </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 - IMMU-114-01[/INST] IMMU-114 will be studied at different dose schedules and dose levels in order to assess the highest dose safely tolerated. IMMU-114 will be administered subcutaneously (under the skin). IMMU-114 will be given 1-2 times weekly for 3 weeks followed by one week of rest. This is considered one cycle. Treatment cycles will be repeated until toxicity or worsening of disease. </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 - Study 001[/INST] A Lead-in Phase II Multicentre, Randomised, Double-Blind Study Comparing AZD1775 plus antimitotic agent and Placebo plus an antimitotic agent in Previously Treated Non-Small-Cell Lung Cancer 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 II - CHBC[/INST] Little is known about the nature and extent of the disturbance in hepatic function and biliary hepatic clearance in chronic viral hepatitis, while the course of this disease, the functional implications and response to treatment are difficult to predict. This study aims to assess this in patients with chronic viral hepatitis B (CHB) and chronic viral hepatitis C (CHC) who are eligible for treatment in accordance with the established consensus guidelines in the involved countries. The pharmacokinetics of NRL972 will be determined at baseline (within one month of starting treatment), at 3-monthly intervals during treatment, for up to 12 months (or at the end of treatment), and at 3 and 6 months after the end on treatment. This will provide a clearer understanding regarding the use of the pharmacokinetics of NRL972 in detecting changes in biliary clearance during and after treatment for CHB and CHC. </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/Nivolumab[/INST] The study will evaluate the clinical activity of PD-(L)1 Checkpoint Inhibitor regimens in combination with the investigational agent sitravatinib in patients with advanced or metastatic urothelial carcinoma. </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 - TRINOVA-3 (w/Paclitaxel/Carboplatin)[/INST] The purpose of this study is to determine whether AMG 386 or AMG 386 Placebo in combination with Paclitaxel and Carboplatin are effective in the treatment of ovarian cancer. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> One of the few treatment options currently FDA approved for recurrent WHO Grade IV malignant glioma is BEV. Additional treatment options are needed for these subjects. Published literature indicates that targeting the proteasome in glioma cells has shown significant anti-tumor activity. MRZ is a novel, second generation proteasome inhibitor that prevents the breakdown of proteins involved in signal transduction which blocks growth and survival of cancer cells. In-vitro studies of multiple glioma cell lines were highly sensitive to MRZ. MRZ had relatively little effect on neural stem/progenitor cells suggesting minimal neurotoxicity while significantly affecting both malignant glioma stem cells and glioma cell lines. Parts 1 and 2 of this trial have been completed with the Recommended Part 3 (Phase 2) Dose established at 0.8 mg/m2. Part 3 of this trial is enrolling at the MRZ RP2D determined in Phase 1 to assess the combination of MRZ and BEV activity and safety. Parts 1, 2, 3 and 4 of this trial have been completed with the Recommended Dose established at 0.8 mg/m2. Part 5 of this trial is enrolling. [/INST] This is a Phase 1/2 clinical trial to evaluate a new combination of drugs, marizomib (MRZ) and bevacizumab (BEV; Avastin®), for the treatment of WHO Grade IV malignant glioma. The study population includes subjects who are in first or second relapse and who have not previously received any bevacizumab or other anti-angiogenic agent or proteasome inhibitor for treatment of malignant glioma. Part 1 Phase 1 evaluates the combination of MRZ and BEV, while Part 2 Phase 2 evaluates single-agent MRZ. Part 3 (Phase 2) includes a combination MRZ using intra-patient dose escalation, and BEV at a fixed dose. Part 4 Phase 1 evaluates MRZ through enteral administration, and BEV at a fixed dose. Part 5 Phase 1 evaluates the repeat-dose pharmacokinetics of MRZ administered IV with ECG. </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 - GBT440-002[/INST] This study will provide information regarding the metabolic pathway of GBT440, the need for evaluation of potential drug-drug interactions, and the need for studies in special populations. The administration of radiolabeled drug is necessary to fully characterize the rates and routes of elimination of GBT440, providing further quantitative information on the disposition of GBT440. The results from this study will permit a comprehensive comparison between animal and human routes of elimination and metabolic profiles of GBT440. </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 - India[/INST] Study design: Single-blind (subject and observer-blinded), active-controlled, randomized [6:2:1:2:1; CL184 + purified vero cell rabies vaccine (PVRV) vs. human rabies immune globulin (HRIG) + PVRV vs. placebo + PVRV vs. CL184 + human diploid cell vaccine (HDCV) vs. placebo + HDCV], mono-center study Study objectives: Primary: To evaluate the safety of CL184 in combination with PVRV in healthy adult subjects. Secondary: To evaluate the safety of HRIG or placebo in combination with PVRV and to evaluate the safety of CL184 or placebo in combination with HDCV in healthy adult subjects. To evaluate the rabies virus neutralizing activity (RVNA) after administration of CL184 or placebo in combination with PVRV, of HRIG in combination with PVRV, and of CL184 or placebo in combination with HDCV in healthy adult subjects. To evaluate the pharmacokinetics of the monoclonal antibodies (mAbs). </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 - Japan[/INST] The purpose of this study is to assess the efficacy and safety of OPA-15406 ointment in patients with atopic dermatitis. </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 - vs. Vehicle[/INST] The purpose of this study is to evaluate the clinical efficacy and safety of ISV-305 (Dexamethasone in DuraSite® 2) compared to Vehicle in the treatment of subjects with active, symptomatic Blepharitis. </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 - c-Met+[/INST] This study is designed to identify the target Non-Small Cell Lung Cancer (NSCLC) population(s) that overexpress c-Met (c-Met+) best suited for telisotuzumab vedotin therapy in the second line or third line setting (Stage 1) and then to expand the group(s) to further evaluate efficacy in the selected population(s) (Stage 2). After the Stage 2 global enrollment is completed, an additional cohort at an alternate dose level will evaluate the safety and efficacy of telisotuzumab vedotin (Stage 3). </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 - Severe NVD (OP-NYX-01a2)[/INST] The objectives of this study are: - To evaluate the efficacy of phentolamine mesylate 0.5% and 1.0% ophthalmic solution (Nyxol) in the treatment of night vision complaints, including reduced contrast sensitivity - To evaluate the ocular and systemic safety of phentolamine mesylate 0.5% and 1.0% ophthalmic solution (Nyxol) compared to its vehicle, a sterile, isotonic, buffered aqueous solution containing mannitol and sodium acetate </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/Avastin[/INST] This study to evaluate treatment in patients with metastatic renal cell carcinoma (RCC) which has progressed through 2 to 3 prior lines of therapy, with the investigational drug CRLX101 in combination with bevacizumab compared to treatment with a standard of care therapy. The study will compare which treatment resulted in longer time before progression of the RCC. Patients will be treated and followed for progression of their disease on average for up to 6 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 III - Japan[/INST] The purpose of this phase 3 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of postoperative inflammation. </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 - Metastatic Cancer[/INST] Aim of the study is to evaluate the safety and find the maximal tolerated dose of VB-111 in Patients with Advanced Metastatic Cancer </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> Male or female patients ≥18 years of age with a histologically confirmed locally advanced and/or metastatic solid organ tumor. Patients enrolled in Germany were required to have a positive EGFR overexpression status. Patients must have experienced a failure or non-availability of standard therapy (had received at least one line of chemotherapy and further standard therapy was not an option at study entry). Open-label, non-randomized, inter-patient dose-escalation, multi-center study. Patients were to receive CetuGEX until disease progression or until intolerable toxicities occurred. [/INST] This was a prospective, open label, multicenter study evaluating the safety, tolerability and pharmacokinetics of CetuGEX™ after intravenous administration in patients with EGFR positive, locally advanced and/or metastatic solid cancers. The effect of CetuGEX™ on the development of anti-drug antibodies and on tumour response was also evaluated. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This study will be conducted in two parts: Part A (Dose Escalation): The purpose of Part A is to determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D). Part A will include any type of HER2-positive solid cancer. Part B (Dose Expansion): The purpose of Part B is to confirm the safety and tolerability of MT-5111 doses selected from those explored in Part A including the MTD or RP2D. Part B will include 3 types of HER2-positive solid cancers in the following 3 expansion groups: Group B1: Breast cancer; Group B2: gastric or gastroesophageal adenocarcinomas (GEA); and Group B3: Other HER2-positive solid cancers. The Breast Cancer cohort will start enrolling in parallel to Part A. Up to 178 eligible subjects will be identified and treated through competitive enrollment at multiple study centers globally In Parts A and B of the study, a subject may participate for the following four periods: Screening (up to 28 days before first dose of MT-5111) Treatment period (active period where a subject will receive three weekly doses of MT-5111 over a 21-day treatment cycle) Short-term Follow-up (30 days after last dose of MT-5111) Long-term follow-up (up to 24 months after the last dose of MT-5111) MT-5111 will be given as an intravenous (IV) infusion over about 30 minutes on the same day every week (i.e., on day 1, day 8 and day 15 of each cycle, a cycle being defined as 21 days). A subject can continue receiving MT-5111 as long as it is well-tolerated, their disease has not worsened, or until the subject decides they no longer want to participate in the study. [/INST] This will be a Phase 1b, first in human, open-label, dose escalation and expansion study of MT-5111 (a recombinant fusion protein) given as monotherapy in subjects with HER2-positive solid tumors </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 - vs Baclofen[/INST] This is a multicenter, randomized (1:1:1), double-blind, active and placebo controlled, parallel group study to evaluate safety, tolerability and efficacy of oral arbaclofen in MS patients with spasticity. Eligible subjects will be removed from anti-spasticity medications for at least one week and then begin study drug treatment with daily doses increasing up to the target dose which will then be maintained for at least 12 weeks. A down-titration will then occur over two weeks. </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/Sorafenib[/INST] The purpose of this study is to determine if VT-122 provides a clinical benefit when added to Sorafenib in patients with advanced hepatocellular carcinoma (HCC). </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> Researchers doing this study also want to evaluate the side effects of Reolysin when given together with docetaxel and prednisone. [/INST] The purpose of this study is to find out if giving Reolysin in combination with docetaxel and prednisone can offer better results than standard therapy with docetaxel and prednisone. </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 - 205165[/INST] The primary purpose of this study is to assess the equivalence of closed triple therapy Fluticasone Furoate (FF)/Umeclidinium (UMEC)/Vilanterol (VI) to open triple therapy (FF/VI + UMEC), with a comparison of both triple therapies to dual therapy (FF/VI) on lung function. This is a phase III, 4-week, randomized, double-blind, parallel group, multicenter study comparing FF/UMEC/VI (100 micrograms [mcg]/62.5 mcg/25 mcg) delivered via a single ELLIPTA® inhaler ('closed' triple) + matching placebo ELLIPTA inhaler, FF/VI + UMEC delivered via two ELLIPTA inhalers ('open' triple) and FF/VI via a single ELLIPTA inhaler + matching placebo ELLIPTA inhaler, all once daily. The total duration of subject participation will be approximately 7 weeks, consisting of a 2-week run-in period, 4-week treatment period and a 1-week follow-up period. ELLIPTA is a registered trade mark of the GSK group of companies. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This is a multi-center, randomized, double-blind, and placebo-controlled phase 3 study evaluating the safety and efficacy of HP-5000 in subjects with OA pain of the knees. The study will consist of up to a 28-day Screening Phase that will include a Washout Period of current prescription and over the counter (OTC) analgesics; a 12-week Double-blind Treatment Phase, and a 1-week safety Follow-up Phase. [/INST] A 12-week, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase 3 study to Evaluate the Efficacy and Safety of HP-5000 in Subjects with Osteoarthritis (OA) Pain of the Knee </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. Avonex[/INST] The purpose of this study is to evaluate the safety and tolerability of ascending intravenous (IV) and subcutaneous (SC) doses of MEDI-551 in adult subjects with relapsing forms of multiple sclerosis (MS). </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 - 16026A (EU)[/INST] The purpose of this study is to determine if multiple immunizations with Lu AF20513 is tolerable and safe in patients with mild Alzheimer's disease. </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 - VALOR (PGTC Seizures)[/INST] Evaluating efficacy & safety of lacosamide versus Placebo in a blinded fashion as add-on Therapy for Primary Generalized Tonic-clonic (PGTC) seizures in subject 4 years of age or greater with idiopathic generalized epilepsy currently taking 1 to 3 antiepileptic drugs. Maximum duration of study drug administration is 28 weeks. Eligible subjects may choose to enter the open-label extension study after completion. </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 - SELECT[/INST] Selexipag is available in many countries for the treatment of pulmonary arterial hypertension (PAH). Due to the similarities between PAH and chronic thromboembolic pulmonary hypertension (CTEPH) and the observed efficacy of other PAH medicines in CTEPH, it is believed that selexipag could benefit to patients with CTEPH. This study aims to assess the efficacy and safety of selexipag in participants with inoperable or persistent/recurrent CTEPH. </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 - Singapore General Hospital[/INST] The coronavirus disease 2019 (COVID-19) has rapidly become a pandemic. COVID-19 poses a mortality risk of 3-7%, rising to 20% in older patients with co-morbidities. Of all infected patients, 15-20% will develop severe respiratory symptoms necessitating hospital admission. Around 5% of patients will require invasive mechanical ventilation, and up to 50% will die. Evidence in severe COVID-19 suggests that these patients experience cytokine storm and progressed rapidly with acute respiratory distress syndrome and eventual multi-organ failure. Early identification and immediate treatment of hyperinflammation is thus recommended to reduce mortality. Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) has been shown to be a myelopoietic growth factor that has pleiotropic effects in promoting the differentiation of immature precursors into polymorphonuclear neutrophils, monocytes/ macrophages and dendritic cells, and also in controlling the function of fully mature myeloid cells. It plays an important role in priming monocytes for production of proinflammatory cytokines under TLR and NLR stimulation. It has a broad impact on the processes driving DC differentiation and affects DC effector function at the mature state. Importantly, GM-CSF plays a critical role in host defense and stimulating antiviral immunity. Detailed studies have also shown that GM-CSF is necessary for the maturation of alveolar macrophages from foetal monocytes and the maintenance of these cells in adulthood. The known toxicology, pharmacologic and safety data also support the use of Leukine® in hypoxic respiratory failure and ARDS due to COVID-19. This study aims to recruit patients with evidence of pneumonia and hypoxia who have increased risk for severe disease and need for mechanical ventilation. The overall hypothesis is that GM-CSF has antiviral immunity, can provide the stimulus to restore immune homeostasis in the lung with acute lung injury from COVID-19, and can promote lung repair mechanisms, which would lead to improvement in lung oxygenation parameters. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This study will consist of a Screening Period, a 7-day Run-in Period, a 12 week Treatment Period, and a Follow-up Visit (approximately 7 to 10 days after the last dose of study drug). Informed consent will be obtained prior to performing any study-specific procedures. Screening will occur within 7 to 28 days prior to randomization to assess eligibility. If patients continue to meet all inclusion and no exclusion criteria at the end of the 7-day Run-in Period, they will be randomized in a 1:1:1:1 ratio to receive orally once daily either placebo or CR845 tablets at doses of 0.25, 0.5 or 1 mg. Randomization will be stratified according to the patient's renal disease status: moderate CKD; severe CKD non-dialysis; severe CKD on dialysis (ie, 3 categories). A final safety Follow-up Visit will be conducted 7 to 10 days after the last dose of study drug. [/INST] This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of 3 dose levels of oral CR845 compared to placebo in reducing the intensity of itch in chronic kidney disease (CKD) patients with moderate-to-severe pruritus. This study will consist of a Screening Period, a 7-day Run-in Period, a 12 week Treatment Period, and a Follow-up Visit (approximately 7 days after the last dose of 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 IV - Td537[/INST] The purpose of this study is to describe the safety and immunogenicity of repeat administration of Adacel vaccine approximately 10 years following initial administration of the vaccine. Antibody levels prior to revaccination will also be used to characterize antibody persistence following initial vaccination 10 years earlier. Primary Objectives: - To compare seroprotection rates against tetanus and diphtheria induced by Adacel vaccine to those induced by Td Adsorbed vaccine. - To compare booster response rates against tetanus and diphtheria induced by Adacel vaccine to those induced by Td Adsorbed vaccine. - To compare anti-pertussis geometric mean antibody concentrations (GMCs) induced by Adacel vaccine to the GMCs induced by Daptacel® vaccine given to infants. Secondary Objectives: - To describe the rates of immediate reactions, solicited reactions, unsolicited adverse events (AEs), and serious adverse events (SAEs) following vaccination with Adacel or Td Adsorbed vaccine. - To describe booster response rates for pertussis antigens following revaccination with Adacel vaccine. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This is an open-label (patients and their doctors will know the identity of study drug administered), uncontrolled (patients are not assigned to treatment by chance), multicenter safety study of escalating dose levels of abiraterone acetate administered in combination with docetaxel plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC). This study is conducted in 2 parts. Part I consists of Screening, Treatment, assessment of dose-limiting toxicity (DLT), and determination of the maximum tolerated dose (MTD). Participants are enrolled in sequential 6-subject cohorts (groups) and administered combination therapy (abiraterone acetate and docetaxel plus prednisone) according to a dose-escalation schedule. The abiraterone acetate dose in this study will escalate from 500 mg to 1000 mg daily until the MTD is determined. The MTD is the highest combination dose among the dose combinations investigated in this study at which no more than 2 (33%) of the patients in a cohort experience a DLT. A DLT is defined by an adverse event occurring from Day 1 Week 2 (first dose of abiraterone acetate) to the day before the Day 1 Week 7 docetaxel infusion (3 weeks after the second docetaxel infusion); non-hematological toxicity >=Grade 3; Grade 4 neutropenia lasting more than 5 days, neutropenia complicated by fever, or systemic infection; thrombocytopenia <25,000/mcL, or any thrombocytopenia requiring platelet transfusion; and, any subjectively intolerable toxicity. Part II of the study consists of Continuing Treatment, when patients remain at the allocated dose level, escalate to the combination MTD, or discontinuation of docetaxel (if toxicity or intolerability develops) and continue abiraterone acetate (up to 1000 mg/day) plus prednisone, until disease progression; End of Treatment, when posttreatment efficacy and safety will be documented; and Follow-Up, when survival status and new antitumor therapy are monitored. Blood samples for pharmacokinetic and efficacy measurements will be collected at selected times during the study. Safety will be monitored. The total duration of study participation may be up to 36 months. Oral abiraterone acetate will be administered as a single daily dose (500, 750, or 1000 mg). Docetaxel will be administered once every 3 weeks as an intravenous (IV) infusion (60 or 75 mg/m2) over 1 hour. Study participants will premedicate with oral dexamethasone 8 mg 1, 3, and 12 hours before the start of each docetaxel IV infusion. Oral prednisone 5 mg will be administered twice daily. [/INST] The purpose of this study is to evaluate the maximum safe dose of abiraterone acetate administered in combination with docetaxel plus prednisone in patients with metastatic castration-resistant prostate cancer (mCRPC). </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/Methotrexate[/INST] The hypothesis of this study is that the p38 inhibitor (PH-797804) will be safe and well tolerated in subjects with rheumatoid arthritis who are taking methotrexate and will not effect the blood levels of methotrexate. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This is a first-in-human, Phase 1/2, multicenter, open-label study to evaluate the safety, PK, PDy, and preliminary anti-tumor activity of ARX517 as monotherapy or in combination in adult subjects with mCRPC with serum testosterone level < 50 ng/dL at screening who are resistant or refractory to standard therapies. Phase 1a (dose-escalation) and Phase 1b (dose-expansion) stages will identify the MTD and/or RP2Ds. Phase 2 will randomize subjects to receive ARX517 at the RP2Ds or ICT as comparator. The ICT to be used in Phase 2 will be determined after reviewing all available clinical data in Phase 1. [/INST] This is a phase 1/2 study to assess the safety and tolerability of ARX517 as monotherapy or in combination in adult subjects with Metastatic castration-resistant prostate cancer (mCRPC). </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> After the phase I/II CG0070 trial review, it became apparent that the use of CG0070 oncolytic vaccine as an intravesical agent for oncolytic lysis of tumor cells, together with the transcription of GM-CSF on site, may have distinct advantages. This first study showed excellent tumor response rates of 48-77% depending on the dose schedule administered. All of these patients had residual non-muscle invasive bladder cancer who have previously failed BCG therapy at the time of treatment. With the addition of a transduction agent such as DDM, the intravesical instillation of CG0070 enabled uniform distribution of viral particles and exposure to the tumor during those 30-60 minutes instillations as contrast to the intra-tumor injection, intra-arterial or intravenous injection of viral particles in other oncolytic viral trials. Some or most of these delivering methodologies have obvious intrinsic imperfections and potential toxicity. This unique opportunity of an relatively easy intravesical tumor exposure is difficult to duplicate in other solid tumor models. The replication of CG0070 in the majority of patients during the first phase I/II trial indicated tumor lysis with release of tumor specific or tumor associated antigens that have been stably expressed, in abundant quantities during tumor cell death. Release of tumor antigens have been the key elements, together with sufficient on-site GM-CSF, in stimulating strong cross-presentation and confirmation signals to the antigen presenting cells such as dendritic cells interacting with CD4+ and CD8+ T cells. This concept of a "real time" vaccine like regimen is expected to compare favorably with other forms of cancer immunotherapy treatment such as BCG in this patient population. It is with this thought that CG0070 may find a success in this setting because of a reasonably and proven complete response rate in residual and failed BCG bladder cancer patients in the first phase I/II study (some cases with only one instillation). Of importance as well, is the demonstration in the study data of a strong GM-CSF expression during its replication phase. Those patients with carcinoma in situ disease and those with RB pathway dysfunction were particularly responsive. It is therefore, desirable to formulate a protocol to encompass the specialty of this oncolytic vaccine and the unique intravesical delivery to prove the efficacy by a randomized controlled study. This opportunity allows a study on the CG0070's beneficial effects, if any, on the standard of care for carcinoma in situ non muscle invasive bladder cancer patients after they failed BCG therapy. The prognosis of this group presently depends mainly on early radical cystectomy, which carries a high morbidity and decrease of quality of life generally viewed as unacceptable for this group of older patients. [/INST] The use of a designed viral vector that can destroy cancer cells while leaving normal cells largely unharmed. The virus also stimulates an immunological response by producing a special factor (GM-CSF) to attract and promote the development of dendritic and T effector cells. It forms the hypothesis that this regimen may be used for people who have failed current forms of treatment and are recommended for cystectomy. It is with hope that this novel therapy will be able to delay or potentially avoid cystectomy for this patient population. Bladder instillation of this agent causes little long lasting side effects and may drastically improve the stimulation of the immune system for local cancer cell death as well as destroying those tumor cells that may have travelled to regional lymph nodes or distant organs. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This is a single-blind, exploratory, placebo-controlled, pilot study to assess the efficacy and safety of daily oral NYX-2925 in fibromyalgia subjects. The study will include a screening period (up to 30 days), a placebo period, an active treatment period with, and a follow-up period as follows: - Placebo PO Every Day (QD) for 2 weeks - NYX-2925 PO QD for 2 weeks (2x) - Follow-up for 1 week Eligible subjects will receive MRIs during the screening period, during the placebo period, during the NYX-2925 PO QD period. Safety assessments will be conducted and adverse events will be collected during the study. Daily pain scores and other fibromyalgia scales will be collected during the study. Daily pain scores and other fibromyalgia scales will be collected for exploratory analysis. During the follow-up period, an optional MRI will be completed for consenting subjects in order to evaluate duration of effect. [/INST] The primary objective is to determine whether daily dosing with NYX-2925 changes markers of central pain processing in subjects with fibromyalgia by evaluating changes in evoked pain, and visual stimulation, functional magnetic resonance imaging (fMRI), resting state function connectivity magnetic resonance imaging (rs-fcMRI) and proton magnetic resonance spectroscopy (H-MRS) in fibromyalgia subjects on active drug versus placebo. </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 - APOLLO-1 (Bunionectomy Surgery)[/INST] The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine administered as needed (PRN) compared with placebo in patients with moderate to severe acute postoperative pain after bunionectomy. </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 - RGH-MD-76[/INST] The objective of this study is to evaluate the long-term safety and tolerability of cariprazine as an adjunctive treatment to antidepressant therapy (ADT) 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 II - ABS-AS-201[/INST] This study is examining how well a dry powder inhaler (DPI) of albuterol medication works to help adult and adolescent subjects 12 years of age and older with persistent asthma to improve lung function. </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 - NSCLC/Melanoma[/INST] This proposed first-in-human study (408-C-1303) is designed to assess the safety, maximum tolerated dose, pharmacodynamics, and pharmacokinetics of omaveloxolone (RTA 408) in patients with advanced solid tumors that are refractory after standard of care therapy for the disease. The results of this study will help provide clinical information for the design and conduct of further clinical studies with RTA 408 in cancer 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 - Bronchoscopy (US)[/INST] A prospective, double-blind, randomized, placebo and active controlled, multi-center, parallel group study comparing remimazolam to placebo, with an additional open label arm for midazolam, in patients undergoing a bronchoscopy. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This study was a double-blind, randomized, multicenter, placebo-controlled, parallel-group study in patients with a diagnosis of chronic inflammatory demyelinating polyradiculoneuropathy and treated with IVIg, corticosteroids, or both therapies prior to study entry. Patients meeting the eligibility criteria were randomly assigned in a ratio of 1:1 to receive oral fingolimod (0.5 mg/day) or matching placebo. The study consisted of 3 periods: a Screening Period, a Double-blind Treatment Period and a Follow-up Period after discontinuation of study drug treatment. Patients who complete the study will have an option to enter an extension. [/INST] The study was designed to evaluate the efficacy and safety of fingolimod in the treatment of chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> A 6-month, Randomised, Double-blind, Placebo-controlled, Multi-centre, Parallel-group, Phase II Study with an Optional Safety Extension Treatment Period up to 6 months, to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled Persistent Asthma [/INST] The purpose is to Evaluate the Efficacy, Safety, and Tolerability of 3 Different Doses of AZD5069 Twice Daily as Add-on Treatment to Medium to High Dose Inhaled Corticosteroids (ICS) and Long-acting β2 Agonists (LABA), in Patients with Uncontrolled Persistent Asthma </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> The study will investigate the tolerability of Modufolin at four (4) different dose levels (30 to 240 mg/m2) in therapy combinations with the chemotherapeutic agents 5-FU, Oxaliplatin +/- bevcizumab, and Irinotecan. When the selected phase 2 dose is determined, 40 additional patients, will be included in the study in order to acquire more data on the safety and tolerability of Modufolin at this dose level. Twenty (20) of these additional patients will be treated in with Oxaliplatin, 20 with Irinotecan. [/INST] The purpose is to characterise the tolerability of Modufolin (arfolitixorin) in combination with 5-FU alone, in combination with 5-FU and Oxaliplatin, in combination with 5-FU and Irinotecan and in combination with 5-FU, Oxaliplatin and Bevacizumab. Another purpose is to investigate 4 doses of Modufolin to identify the best dose for further assessment. </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 - TLC399.1 (Taiwan)[/INST] To determine whether TLC399 (ProDex) provides an ideal, safe, long-acting, dexamethasone sodium phosphate (DSP) delivery system for the treatment of macular edema due to retinal vein occlusion (RVO). </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 - NATRUL-4[/INST] A study with an 8 week open label phase study followed by a year long placebo controlled maintenance phase in subjects with active mild to moderate ulcerative colitis (UC), with a modified Mayo Score 4-10 and an endoscopy subscore of 2-3, taking mesalamine (or equivalent) as a concomitant medication. Subjects are required to be in clinical remission or clinical response to enter the year long maintenance phase. This study will help evaluate if HMPL-004 is effective in subjects maintaining clinical remission following successful induction therapy achieving clinical remission or clinical response. </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 - MACS2096 (4EVER; HER2-/HR+)[/INST] The present multi-center, open-label, single-arm study aims to evaluate the efficacy and safety, quality of life and health resources utilization in postmenopausal women with hormone receptor positive breast cancer progressing following prior therapy with non-steroidal aromatase inhibitors (NSAI) treated with the combination of Everolimus and Exemestane. </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 - Extension of A3921009[/INST] A new immunosuppressive drug, based on the inhibition of an important enzyme in the immune system called JAK3, is being developed by Pfizer to prevent transplant rejection. In study A3921009, kidney transplant patients were given a JAK inhibitor or tacrolimus for 6 months posttransplant. Patients who completed study A3921009 were offered the opportunity to participate in study A3921021 which will extend the evaluation of safety and efficacy of CP-690,550 versus tacrolimus through 8 years posttransplant. In treatment group 1 (control arm), subjects will continue to receive tacrolimus. In treatment groups 2 and 3, subjects will continue to receive CP-690,550. Per Amendment 4, the tacrolimus comparator arm will be discontinued. </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 - Two-way Crossover Study[/INST] The purpose of this study was to evaluate the efficacy, safety, and pharmacokinetics of switching FK949E (sustained-release quetiapine) 50-mg and 150-mg tablets to the other tablet at the equivalent total daily dose in bipolar disorder patients with major depressive episodes. </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 (MDD-301)[/INST] This study is a phase 3, multicenter, double-blind, randomized, placebo-controlled study evaluating the efficacy of SAGE-217 in the treatment of adult participants 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 - Optimal Dose Study (Healthy Volunteers)[/INST] The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of IV migalastat HCl alone and to determine absolute bioavailability for oral migalastat HCl as compared to IV administered migalastat HCl in healthy volunteers. The data from this study will help us understand how migalastat works in the body and will help us determine what would be an effective dose in future studies with migalastat hydrochloride. </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 - Idiopathic PD[/INST] This is a study with two sequential cohorts, each with three treatment periods. Single doses of PF-06649751 will be tested in this study, starting at a low dose and escalating to a dose projected to be under the current limits for drug concentration. Each cohort will aim to achieve approximately 9 completers. Primary endpoint is safety and tolerability, secondary endpoint is MDS-UPDRS part III. </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 - Long Term Safety[/INST] To evaluate the long term safety of repeat dose OTX-TP, a sustained release travoprost drug product, placed in the canaliculus of the eyelid in the treatment of subjects with open-angle glaucoma or ocular hypertension. </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 - M16-553 (w/SC-004)[/INST] This is a two-part study consisting of Part A (dose regimen finding) followed by Part B (dose expansion). Part A (dose regimen finding) will allow definition of the maximum tolerated dose (MTD) through dose escalation and possible dose interval modification. In Part B (dose expansion), potential therapeutic doses may be studied with SC-004 as monotherapy and SC-004 in combination with ABBV-181 in disease-specific cohorts. </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 - B7471011- VACCINE IN HEALTHY INFANTS[/INST] 20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants </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/IIa - Healthy Volunteers (Australia/Canada)[/INST] The purpose of the first part of this study is to determine the safety and tolerability of a single dose of AEM-28, an apolipoprotein E mimetic, in subjects with high total cholesterol who are otherwise healthy subjects. The pharmacokinetics and pharmacodynamics of AEM-28 will also be evaluated. The second part of this study will be a multiple ascending dose evaluation of AEM-28 in patients with refractory hypercholesterolemia. AEM-28 has demonstrated significant lipid lowering activity and positive effects on the artery wall. AEM-28 is being developed for the treatment of homozygous familial hypercholesterolemia. </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 - SAD/MAD (Healthy Volunteers)[/INST] The main purpose of the study is to determine if PF-06700841 is safe and well tolerated when administered to humans. A secondary purpose is to assess what the body does to PF-06700841 and to assess what PF-06700841 does to the body when given as single and multiple doses. The pharmacokinetic properties of different forms of PF-06700841 may be studied (tablet and solution/suspension forms). </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 - TK007[/INST] The aim of the study is to obtain immune reconsitutuion as well as reduction of infective episodes and disease relapse in patient with haematological malignancies who underwent SCT(and subsequent T lymphocytes infusions) and selectively controlling GvHD. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> In this study, patients were to receive a maximum of 24 doses of recNY-ESO-1 + AS15 ASCI according four cycles over a period of four years. An active follow-phase (up to five years after registration into the study) was planned for all patients. As of Amendment 3, there will no longer be an active follow-up of patients after discontinuation or completion of the treatment. The study will end 30 days after the last dose will be administered. In addition, no more biological samples will be collected for protocol research purposes. For each biological sample already collected in the scope of this study and not tested yet, testing will not be performed by default, except if a scientific rationale remains relevant. Blood sampling for safety monitoring as per protocol will continue. [/INST] The purpose of this study is to investigate the safety, immunogenicity and clinical activity of GSK2241658A antigen-specific cancer immunotherapeutic (ASCI) for the treatment of patients with non-operable and progressing metastatic cutaneous melanoma. </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 - Cerebral Palsy[/INST] A double-blind, placebo-controlled, crossover study in subjects with cerebral palsy (CP) to evaluate the safety and tolerability and the effect of dalfampridine extended release (ER) tablets on sensorimotor function </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 - 2001 (Japanese Patients)[/INST] This primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic properties of multiple ascending doses of ATN-103 administered subcutaneously (below the skin) to Japanese subjects with active rheumatoid arthritis and on a stable background of methotrexate. Some subjects will receive ATN-103 while other subjects will receive a placebo. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This is a first-in-human, multi-center, open-label clinical study with separate Dose Escalation and Expansion Phases to assess preliminary safety, tolerability, and efficacy of KPT-9274, a dual inhibitor of PAK4 and NAMPT, in patients with advanced solid malignancies (including sarcoma, colon, lung, melanoma, etc.) or NHL for which all standard therapeutic options considered useful by the investigator have been exhausted. [/INST] This study will evaluate the safety, tolerability, and efficacy of oral KPT-9274 for the treatment of patients with advanced solid malignancies or non-Hodgkin's lymphoma (NHL). Currently enrolling melanoma patients in combination with nivolumab, only. </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 - AURORA[/INST] This is a Phase 3, prospective, open-label, international, multicentre study of Flurpiridaz (18F) Injection for PET MPI in patients referred for ICA because of suspected CAD. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with bilateral geographic atrophy (GA) age-related macular degeneration (AMD). All subjects will be assigned to HUCNS-SC transplantation. All subjects will be followed for efficacy and safety for 12 months. An independent data monitoring committee (IDMC) will review adverse events for the duration of the study. [/INST] A fellow eye controlled study of HUCNS-SC sub-retinal transplantation in subjects with bilateral GA AMD. All subjects will be assigned to HUCNS-SC transplantation. </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 - Ibrutinib Intolerant[/INST] The primary objective of this study is to evaluate the safety of zanubrutinib (also known as BGB-3111) in chronic lymphocytic leukemia/small lymphocytic lymphoma, Waldenström macroglobulinemia, mantle cell lymphoma, or marginal zone lymphoma patients who have become intolerant of prior ibrutinib and/or acalabrutinib treatment, by comparing intolerance to adverse event profile as assessed by the recurrence and the change in severity of adverse events. </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 - ASPIRE (Russia)[/INST] The purpose of this study is to determine whether a single intracoronary infusion of Ad5FGF-4, delivered during induced transient ischemia, is effective in improving myocardial perfusion, angina functional class, patient symptoms, and quality of life. Short-term (8 weeks) and long-term (12 month) safety of Ad5FGF-4 will also be evaluated. The primary endpoint is change in adenosine triphosphate (ATP) stress SPECT reperfusion defect size. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> Lenalidomide is designed to change the body's immune system. It may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may decrease or prevent the growth of cancer cells. Prednisone is designed to improve the results of lenalidomide and to help reduce the side effects. If you are found to be eligible to take part in this study, you will take 1-2 capsules of lenalidomide by mouth daily. You will take lenalidomide daily for 21 days followed by 1 week rest. This 28-day period is called a study "cycle." Swallow lenalidomide capsules whole with water at the same time each day. Do not break, chew or open the capsules. If you miss a dose of lenalidomide, take it as soon as you remember on the same day. If you miss taking your dose for the entire day, take your regular dose the next scheduled day (do NOT take double your regular dose to make up for the missed dose). You will take prednisone by mouth every day during Cycles 1-2, and every other day during Cycle 3. You may only take prednisone for Cycles 1-3. You will be given a study drug diary. In this diary, you will record when you take the study drug(s). During treatment, blood (about 1 tablespoon) will be drawn once every 1-2 weeks. Following the completion of 24 cycles, blood (about 1 tablespoon) will be drawn every 1- 3 months. The tests may be repeated more frequently to check for side effects. Every month for the first 3 months, and then every 3 months, until you complete 24 cycles, you will have a study visit. You will have a bone marrow biopsy/aspirate every 3 months. Lenalidomide will be provided to you as a monthly (28-day) supply. Following the completion of Cycle 24, you will have a study visit every 6 months. You will have a bone marrow biopsy/aspirate every 12 months. Lenalidomide will be provided to you as a monthly (28-day) supply. Depending on side effects and the activity of the study drug against the disease, your dose of the study drug may be increased or decreased. You may stay on study for as long as you are benefitting. You will be taken off study if you are not or are no longer benefitting or intolerable side effects occur. This is an investigational study. Lenalidomide and prednisone are both FDA approved and commercially available. Lenalidomide is approved by the Food and Drug Administration (FDA) for the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes associated with the chromosome 5 abnormality with or without other chromosome abnormalities. Lenalidomide is also approved in combination with dexamethasone for the treatment of patients with multiple myeloma that have received at least one prior therapy. Myelodysplastic syndrome (MDS) and Multiple Myeloma (MM) are cancers of the blood. It is currently being tested in a variety of cancer conditions. In this case it is considered experimental. Prednisone is on the market for many different things but not specifically for Myelofibrosis. The use of these drugs in combination is considered investigational in this study. Up to 41 patients will take part in this study. All will be enrolled at M. D. Anderson. [/INST] The goal of this clinical research study is to learn if lenalidomide in combination with prednisone can help to control myelofibrosis. The safety of lenalidomide and prednisone for the treatment of myelofibrosis will also be studied. </s>