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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 - ZA-204 - Hypogonadism[/INST] The study will determine the effects of three doses of Androxal(enclomiphene citrate)on morning testosterone versus AndroGel(approved topical treatment)in men with low testosterone (<350 ng/dL)after 6 weeks of continuous dosing. </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, randomized, single-blind, placebo-controlled, multiple-ascending dose (MAD), sequential-group study in healthy Japanese (Part 1, Cohorts 1, 2, and 3) and Chinese (Part 2, Cohort 4) male subjects, conducted at a single study center. Four cohorts are planned, but one additional cohort may be enrolled based on a Safety Review Committee (SRC) decision. The 4 multiple dose levels are planned as follows: - Cohort 1: Dose 1 - Cohort 2: Dose 2 - Cohort 3: Dose 3 - Cohort 4: Dose 2 A randomization ratio of 3:1 (AZD4831 versus placebo) will be used. For each cohort the study will comprise: - Screening Period of a maximum of 28 days. - A Treatment Period during which subjects are resident in the study center from the day before first dosing with the Investigational Medicinal Product (Day -1) until at least 48 hours after last dosing on Day 10; subjects will be discharged on Day 12. - Three Follow-up Visits on Day 14, Day 16 (±1 day), and Day 20 (±1 day). - A Final Follow-up Visit on Day 24 (±2 days). Each subject will be involved in the study for 8 to 9 weeks. [/INST] This study is randomized, single-blind, placebo-controlled Phase 1 study aimed to assess the safety and efficacy, pharmacokinetics and pharmacodynamics of multiple doses of oral AZD4831 in healthy Japanese and Chinese volunteers </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 - 22002 (OLE study)[/INST] Study 22001, "A Double-Blind, Placebo-Controlled, Flexible-Dose Evaluation of the Efficacy, Safety, and Tolerability of STX209 in the Treatment of Irritability in Subjects with Fragile X Syndrome" currently is evaluating the efficacy of STX209 (R-baclofen) for management of typical problem behaviors, such as irritability and aggression, in subjects with FXS. This study (22002) will enter subjects who complete Study 22001 into a long-term, open-label study.The open-label extension protocol will provide necessary data on the long-term safety and tolerability of STX209 among subjects with FXS who receive treatment under conditions more closely reflective of their general medical care. </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, single center study to visually assess and quantitatively compare brain PET images obtained after application of [18F]PI-2620 with different specific activities: 1) High specific activity (low mass dose): 185 MBq containing a maximum mass dose of ≤5 μg in up to 10 mL and 2) Low specific activity (high mass dose): 185 MBq containing a maximum mass dose of 40-50 μg in up to 10 mL). [/INST] This is an open-label study without randomisation. All eligible patients will receive two administrations of the investigational imaging agent [18F]PI-2620 at a radioactive dose of 185 MBq, one with high specific activity (≤ 5 µg tracer mass dose), another one with low specific activity (40-50 µg tracer mass dose). </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> Overall Design: This is a multicenter, open-label, phase Ib/II clinical study of Toripalimab Injection (JS001) in patients with gastric adenocarcinoma (GC), esophageal squamous cell carcinoma (ESCC), nasopharyngeal carcinoma (NPC), or head and neck squamous cell carcinoma (HNSCC). On the basis of the results of safety and pharmacokinetic data in the phase I study of JS001, 3 mg/kg is determined as the recommended dose of the 2-week monotherapy regimen, and no study on the 10 mg/kg cohorts will be conducted any more. And the corresponding 240 mg and 360 mg are determined as the corresponding exploratory doses of the 3-week combined treatment regimens. Eligible subjects will be selected based on the inclusion and exclusion criteria: subjects with gastric adenocarcinoma, esophageal squamous cell carcinoma, nasopharyngeal carcinoma, or head and neck squamous cell carcinoma (cohort 1, 2, 3, 4, respectively) will receive treatment at the dose of 3 mg/kg. While subjects with advanced gastric adenocarcinoma, esophageal squamous cell carcinoma, nasopharyngeal carcinoma, or head and neck squamous cell carcinoma (cohort 5, 6, 7, 8, respectively), who have not received any treatment before, will be treated with the corresponding 3-week regimen of standard first-line chemotherapy combined with JS001 240 mg or 360 mg . Study Treatment: The study on the 3 mg/kg cohorts is planned to be conducted first in cohort 1, 2, 3, 4 in this trial. After enrollment, the subjects will receive study treatment once every 2 weeks (Q2W) with 4 weeks as a cycle, until absence of further benefits judged by the investigator, disease progression, occurrence of intolerable toxicity, investigator's decision, withdrawal of informed consent by the subject, or death. The study of cohort 5, 6, 7, and 8 will be carried out in the sites designated by the sponsor. Subjects will receive corresponding regimen of standard first-line chemotherapy combined with JS001 240 mg or 360 mg once every 3 weeks (Q3W) (see Section 3.1 Overall Design for details). JS001 240 mg or 360 mg Q3W can be administrated after the end of chemotherapy until absence of further benefits judged by the investigator, disease progression, occurrence of intolerable toxicity, investigator's decision, and withdrawal of informed consent by the subject, or death. If the subject experiences disease progression but the subject can still obtain clinical benefit from the study treatment of JS001 according to the investigator, the subject can continue the study treatment if an approval is obtained after discussion between the investigator and the medical monitor from the sponsor or the authorized CRO. If the subject develops disease progression for a second time, he/she should permanently withdraw from the study treatment. Tumor Assessment: During the study, for cohort 1, 2, 3, and 4, tumor responses will be evaluated every 8 weeks in the first year according to RECIST 1.1, and every 12 weeks thereafter. Tumor responses will also be evaluated according to irRECIST at the same frequency with that conducted according to RECIST 1.1 until disease progression, death or loss of follow up (whichever comes first). For cohort 5, 6, 7, and 8, tumor responses will be evaluated every 6 weeks (± 3 days) in the first year according to RECIST 1.1 and irRECIST, and every 12 weeks thereafter until disease progression, death or loss of follow up (whichever comes first). The radiographic data of the subjects will be collected for review by IRC. The IRC will evaluate the corresponding study endpoints based on tumor responses, but no such evaluation is planned for cohort 5, 6, 7 and 8. Pharmacokinetics: At least 10 of the subjects (no requirements on indications) in JS001 3 mg/kg cohorts at the sponsor-designated study sites should complete the pharmacokinetic blood sampling in the first 3 cycles of study treatment until 60 days after the end of study treatment. If a subject did not complete the scheduled sample collection in the first 3 cycles of study treatment due to any reason, another subject should be added. Corresponding pharmacokinetic blood samplings will also be conducted for cohort 5, 6, 7, and 8, to evaluate the pharmacokinetic characteristics of JS001 used in the combined treatment with chemotherapy. At least 3 patients will be selected for blood sampling in each cohort. Acquisition of Tumor Tissue Specimens: Subjects with esophageal squamous cell carcinoma, gastric adenocarcinoma (including adenocarcinoma at esophageal-gastric conjunction), nasopharyngeal carcinoma, or head and neck squamous cell carcinoma must provide acceptable tumor tissue specimens (fresh tumor tissue specimens for biopsy before enrollment are preferred) prior to enrollment for future use in subsequent exploratory studies. Any subject with the response confirmed as partial response (PR) and/or progressive disease (PD) is encouraged to voluntarily participate in the selectable biomarkers study if tumor tissues can be obtained from him/her. And in the selectable biomarkers study, they will provide tumor tissues for exploratory study on the correlation between tumor markers and the level of anti-tumor responses. All the tumor tissue specimens provided will be sent to the designated central laboratory for evaluation. End of Study: The primary endpoint of the study is ORR. The study will be completed at 12 months after the last patient in and data analysis will be conducted then. If by that time there are still some subjects receiving study treatment, these subjects will be transferred to an extension study to continue the study treatment until absence of further benefits judged by investigator, disease progression, occurrence of intolerable toxicity, investigator's decision, withdrawal of informed consent by subject, or death. [/INST] The purpose of this study is to preliminarily evaluate anti-tumor activity of a Recombinant Humanized Anti-PD-1 Monoclonal Antibody for Infusion (JS001) in treating advanced gastric adenocarcinoma, esophageal squamous cell carcinoma, nasopharyngeal carcinoma and head and neck squamous cell carcinoma and to determine the recommended phase II dose (RP2D) </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 - 400-12-002[/INST] This is a three-arm, randomized multicenter study evaluating the safety and effectiveness of EVARREST™ Fibrin Sealant Patch in controlling mild to moderate vascular anastomosis suture line bleeding in cardiovascular surgery. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase IIb - Pilot Study (Israel)[/INST] This is an open, pilot study using the oral ORMD-0801 insulin formulation in patients with NASH and confirmed type 2 DM or pre-diabetes. The study will consist of a Screening, placebo run-in, treatment phase and end-of-study phase. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> The study consists of a screening visit (SV) followed by up to 16 days by a treatment period comprising 5 visits (TV1-TV5). The treatment period visits will each be separated by a washout period lasting 2-7 days. During each treatment period visit, the forced expiratory volume in 1 second (FEV1) will be determined at 30 minutes and again immediately prior to the commencement of study medication administration, and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes after completion of study medication administration. [/INST] This is a multicenter, randomized, double-blind, double-dummy, placebo-controlled, single-dose, 5-treatment, 5-period, 5-way crossover study in pediatric patients with persistent asthma. The primary purpose of this study is to compare the efficacy and safety of Albuterol Spiromax with that of ProAir HFA in pediatric asthma patients at 2 delivered dose levels equivalent to 90 mcg and 180 mcg of albuterol base. </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 - INTELLANCE 2[/INST] This study was conducted to evaluate the efficacy and safety of depatuxizumab mafodotin (ABT-414) alone or with temozolomide versus temozolomide or lomustine alone in adult participants with recurrent glioblastoma. The study also included a substudy to evaluate safety, tolerability and pharmacokinetics of ABT-414 in a pediatric population. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> Tissue factor (TF)-dependent procoagulant activity and associated inflammatory processes may play a role in the severity and progression of ALI/ARDS. Recent studies demonstrated that TF levels were elevated in plasma and pulmonary edema fluid of ARDS/ALI patients compared to control patients with hydrostatic pulmonary edema. These higher plasma TF levels were correlated with increased mortality, fewer ventilation-free days, the presence of disseminated intravascular coagulation and the presence of sepsis in patients with ALI/ARDS, suggesting that systemic activation of coagulation may be clinically important in ALI/ARDS. Moreover, the pulmonary TF levels in patients with ALI/ARDS were found to range between 0.5 and 2 nM, approximately 100-fold higher than simultaneous plasma levels, suggesting an intra-alveolar source of TF. Thus, anti-TF antibody blockage of TF activity may therefore provide an effective therapeutic mechanism for the treatment of inflammatory disorders such as ALI and ARDS. This study will test the hypothesis that administration of anti-TF antibody (ALT-836) to septic patients with ALI/ARDS will improve the clinical outcome by shortening the duration of mechanical ventilation for these patients. [/INST] This is a prospective, randomized (1:1), double-blind, multi-center, Phase II clinical study to test the safety and efficacy of a recombinant chimeric anti-tissue factor antibody (ALT-836) versus placebo in patients with sepsis and acute lung injury/acute respiratory distress syndrome (ALI/ARDS). This study was divided into two parts and the first part of the study has been completed. In the first part of the study, sixty patients were randomized at a 1:1 ratio to receive one dose of the study drug or placebo. In the second part of the study, ninety patients will be randomized at a 1:1 ratio to receive a multi-dose treatment regimen of single doses every 72 hours up to a maximum of 4 doses of the study drug or placebo, provided there are no safety concerns. </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 - 004 vs. Liraglutide[/INST] This is a multicenter randomized, double-blind, placebo- and active-controlled (liraglutide; Victoza®), parallel-group, clinical trial of MK-8521 in participants with type 2 diabetes mellitus (T2DM) with inadequate glycemic control while on a stable dose of metformin (≥1000 mg/day). The trial will include a 1-week screening period; at least an 8-week antihyperglycemic agent (AHA) washout period, if required; a 14-week blinded therapy period (which includes single-blind run-in and double-blind therapy); and a 14-day post-treatment visit, 2 weeks after the last dose of investigational product. The primary hypothesis of the trial is that MK-8521 provides greater reduction in hemoglobin A1C relative to placebo after 12 weeks of once-daily administration in participants with T2DM with inadequate glycemic control on metformin monotherapy. </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 - MASTERS-2[/INST] A Phase 3 study to examine the safety and effectiveness of the allogeneic, adult stem cell investigational product, MultiStem, in adults who have suffered an acute ischemic stroke in the previous 18-36 hours. </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 - Asian Study (113684)[/INST] The purpose of the study is to investigate the efficacy and safety of fluticasone furoate/vilanterol Inhalation Powder compared with placebo over a 24 weeks treatment period in subjects of Asian ancestry with Chronic Obstructive Pulmonary Disease (COPD). </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 - +/- nivolumab[/INST] This study evaluates the post cystectomy CD8+ tumor response of patients receiving Nivolumab plus Urelumab versus Nivolumab alone. Half the patients will receive Nivolumab plus Urelumab, while the other half will receive Nivolumab alone. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This open-label Phase I study aims to define the recommended dose for further clinical development the NKR-2 treatment administered concurrently with AZA in treatment-naïve AML/MDS patients not candidates for intensive induction chemotherapy. The treatment consists in six consecutive cycles of AZA, administered at days 1. to 7 of a 28-day cycle. Patients will be treated with 8 injections of NKR-2 at day 9 and 23 of AZA cycles 2-3-4 and 5. This Phase I study is divided into three sequential cohorts evaluating three different dose-levels of NKR-2 (1x108, 3x108 and 1x109 NKR-2 per injection) using a 3+3 design. Further patients will be enrolled at the RecD to reach 9 evaluable patients in total at the RecD. The study consists of a screening phase, a treatment administration phase and a follow-up phase divided into treatment follow-up (TFU) and long-term safety follow-up (LTSFU). For each patient who received at least one NKR- 2. administration, the overall study duration will be 15 years after first NKR- 2 administration. Patients will be asked to complete a total of 54 visits during the treatment administration phase, and 5 visits during the treatment follow-up phase. During the LTSFU, yearly visits will be scheduled (up to Visit Y15). [/INST] This open-label Phase I study aims to define the recommended dose for further clinical development the NKR-2 treatment administered concurrently with AZA in treatment-naïve AML/MDS patients not candidates for intensive chemotherapy or hematopoietic stem cell transplantation. This Phase I study is divided into three sequential cohorts evaluating three different dose-levels of NKR-2 (1x108, 3x108 and 1x109 NKR-2 per injection) using a 3+3 design evaluate. Further patients will be enrolled at the RecD to reach 9 evaluable patients in total at the RecD. The study consists of a screening phase, a treatment administration phase and a follow-up phase divided into treatment follow-up (TFU) and long-term safety follow-up (LTSFU). For each patient who received at least one NKR-2 administration, the overall study duration will be 15 years after first NKR-2 administration. </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/Azacitidine (US)[/INST] The main purpose of this study is to determine the safe and recommended dose of APR-246 in combination with azacitidine as well as to see if this combination of therapy improves overall survival. </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 - SPR.18142 (Long-Term)[/INST] A long-term, open-label, non-comparative safety and efficacy study of CD07805/47 gel 0.5% once daily in subjects with moderate to severe facial erythema associated with rosacea. </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 - HERALD[/INST] This is a Phase 1b/2 study. In Phase 1b, subjects will know the treatment they are receiving. Subjects will receive Erlotinib + U3-1287. The Phase 1b portion will determine if adding U3-1287 to Erlotinib will be safe in subjects with advanced non-small cell lung cancer who fail prior treatment. In the Phase 2 portion, subjects will be blinded to the treatments they are receiving. Subjects will receive either Erlotinib alone or Erlotinib + U3-1287. The Phase 2 portion will determine if adding U3-1287 to Erlotinib will be safe and improve survival in subjects with advanced non-small cell lung cancer who failed the first treatment. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> An open-label, single-arm, multi-center, phase 1, dose-escalation study will be conducted to define the MTD/RP2D, safety, PK, immunogenicity and antitumor activity of GC1118 in patients with refractory disease for whom no standard therapy is available. This study is in three parts: a dose escalation segment (Part A), a cohort expansion (Part B) and biweekly administration(Part C). In part A, a dose escalation schema will be applied in dose level cohorts. GC1118 will be administered weekly on Study Day 1, 8, 15, and 22 of each 28-day cycle by IV infusion. Dose escalation may occur as described in the study protocol. Once the MTD has been established during Part A, the MTD cohort will be expanded in part B. And GC1118 will be administered biweekly on Study Day 1, 15 each 28-day cycle by IV infusion in part C. Study assessments will include AE monitoring including physical examination, vital signs and clinical laboratory tests, ECG monitoring, PK analysis of serum GC1118, an assessment of potential anti-GC1118 antibody response and an exploration of potential prognostic and pharmacodynamic biomarkers. Tumor response assessments using Study Day 36 CT/MRI scans will be performed approximately five weeks after the first GC1118 dose for each patient (Part A only). Patients with evidence of disease regression (partial or complete response or stable disease by RECIST criteria) will be allowed to continue therapy at the same dose. Subsequent cycles will consist of administration of GC1118 on Day 1, 8, 15, and 22 of each 28-day cycle with tumor evaluation every other cycle (approximately every 8 weeks) in part A,B and Day 1, 15 of each 28-day cycle with tumor evaluation every other cycle (approximately every 8 weeks) in part C. [/INST] The purpose of this study is to determine the maximum tolerated dose(MTD)/Recommended Phase 2 Dose(RP2D) and to evaluate the safety and tolerability of GC1118 when given by intravenous (IV) infusion to patients with stage IV solid tumors. The study will also evaluate pharmacokinetics, immunogenicity and antitumor effect of GC1118 and explore prognostic biomarkers and pharmacodynamic biomarkers. </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 - POM-001[/INST] A Phase 1/2, open-label, multicenter, multiple dose escalation study of BMN 701 administered by intravenous infusion every 2 weeks over a 24-week treatment period to patients with late-onset Pompe 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 Ib - w/Palbociclib (HER2 Negative Subjects)[/INST] The primary objective of this study is to evaluate the safety and tolerability of H3B-6545 and palbociclib when administered in combination in order to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of this combination in women with advanced or metastatic estrogen receptor-positive (ER+) HER2- breast cancer. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This Phase III, randomized, open-label trial will determine whether the regimens of chemotherapy plus trastuzumab plus bevacizumab improve invasive disease-free survival (IDFS) relative to the regimens of chemotherapy plus trastuzumab. Secondary aims include determining whether the addition of bevacizumab to chemotherapy plus trastuzumab will improve disease-free survival (DFS), overall survival (OS), recurrence-free interval (RFI), and distant recurrence-free interval (DRFI). The benefit of adding bevacizumab for IDFS, DFS, OS, RFI, and DRFI will also be evaluated for each of the two chemotherapy regimens. The cardiac and non-cardiac toxicities of each of the regimens will also be evaluated. Following local determination that the tumor is HER2-positive for gene amplification by in situ hybridization or is IHC 2+ or 3+, a tumor sample must be submitted for HER2 testing by a designated central laboratory. If central testing confirms that the tumor is HER2-positive (either positive by FISH or IHC 3+) and all other eligibility criteria have been met, the patient will be randomized to a regimen of chemotherapy and trastuzumab with or without bevacizumab. Patients in the trial will be enrolled in one of two chemotherapy regimen cohorts. One cohort will receive 6 cycles of docetaxel/carboplatin plus trastuzumab (TCH) with or without bevacizumab; the other cohort will receive 3 cycles of docetaxel plus trastuzumab given with or without bevacizumab followed by 3 cycles of 5-Fluorouracil, Epirubicin, Cyclophosphamide (TH-FEC). With both regimens, patients will continue trastuzumab with or without bevacizumab following chemotherapy to complete 1 year of targeted therapy. Following completion of chemotherapy, patients will also receive adjuvant radiotherapy and endocrine therapy as clinically indicated. The trial will be conducted by investigators affiliated with the Cancer International Research Group (CIRG) and the National Surgical Adjuvant Breast and Bowel Project (NSABP). CIRG and NSABP investigators will only enroll patients in the TCH regimen cohort. Additional investigators, referred to in the protocol as Independent Investigators, will enroll patients in both the TCH regimen or the TH-FEC regimen cohort depending on institutional preference for the one regimen that will be used by that institution for the duration of the trial. Patients will be given the option of allowing their tumor samples to be used for the BETH translational research and correlative science studies. Also, patients will be asked to consent to the submission of blood and serum samples at scheduled time points during the study. LVEF assessments will be performed before study entry and then at scheduled time points during therapy and at 18, 36, and 60 months following randomization. The planned sample size for the trial is 3,000 patients randomized in the faster accruing cohort and a minimum of 3,500 patients overall. [/INST] The trial will determine the value of adding bevacizumab to chemotherapy plus trastuzumab in patients with resected node-positive or high risk node-negative, HER2-positive breast 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 III - EVOLVE-1 (Sorafenib Failure)[/INST] The purpose of this study is to compare treatment with RAD001 plus best supportive care (BSC) to placebo plus BSC in patients with advanced HCC whose disease progressed while on or after sorafenib treatment or who are intolerant to sorafenib. </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 - SP0962[/INST] The purpose is to obtain data on the safety and seizure frequency associated with long-term oral Lacosamide for uncontrolled primary generalized tonic-clonic (PGTC) seizures in subjects with idiopathic generalized Epilepsy. Additionally, to allow subjects who have completed SP0961 (NCT01118949) to continue to receive Lacosamide. </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 - Monotherapy (NCI)[/INST] This phase II trial is studying how well PXD101 works in treating patients with relapsed or refractory acute myeloid leukemia or older patients with newly diagnosed acute myeloid leukemia. PXD101 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> After meeting eligibility criteria within each cohort subjects will be randomized to receive a single dose of LIB003. Seven (7) cohorts will receive LIB003 escalating doses of LIB003, or placebo, by SC injection and 2 cohorts LIB003 or placebo by IV infusion. Dose escalation will be based on the assessment of safety and tolerability data. All cohorts will each first enroll a sentinel group of subjects who will receive LIB003 or placebo in a double-blind fashion with the remaining subjects in that cohort only to be dosed after the safety data on day 4 from the sentinel subjects has been assessed and deemed safe. [/INST] Randomized, double-blind, placebo-controlled, single ascending dose study in nine (9) separate and sequential dose cohorts (7 SC and 2 IV cohorts) to assess the safety and tolerability, pharmacokinetics and pharmacodynamics of LIB003 in subjects with moderately elevated LDL-C levels. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This Phase 1, open-label, non-randomized, dose escalation, first-in-human study will assess the safety and tolerability of DS-1055a, determine the maximum tolerated dose of DS-1055a, pharmacokinetic (PK) properties of DS-1055a, and the incidence of anti-drug antibodies (ADAs) against DS-1055a and other antibodies. [/INST] The purpose of this study is to assess the safety and tolerability of DS-1055a in participants with relapsed or refractory locally advanced or metastatic solid tumors for which no standard treatment is available. </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 - Study 094 (REALISTIC)[/INST] This is a Phase IIIb multicenter study to evaluate the safety and efficacy of certolizumab pegol (CZP) administered to patients with moderate-to-severe rheumatoid arthritis. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> All participants who completed the 12-month double-blind study period were eligible to continue in the open-label study. Participants received placebo, Abatacept 2 mg/kg, or Abatacept 10 mg/kg in the double-blind study. Participants receiving placebo in the double-blind study were switched 1:1 to continued treatment with placebo or Abatacept 2 mg/kg. Participants receiving Abatacept 2 mg/kg or Abatacept 10 mg/kg continued at the double-blind study dosage. After results from the double-blind period became available, all participants were switched to a weight-tiered 10 mg/kg dose of Abatacept. Open label study design: Single group assignment, Single arm, Open label, [/INST] This study was conducted to assess the safety and tolerability of Abatacept combined with Methotrexate in participants with active rheumatoid arthritis (RA). The secondary objectives were to assess efficacy, pharmacodynamic marker activity, and immunogenicity of Abatacept combined with Methotrexate. </s>

<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase IIb - vs. Standard of Care[/INST] This is a Phase 2, open-label, randomized, 3-arm trial investigating the efficacy of two Sym004 doses (Arm A and Arm B) compared with a control group (Arm C) in subjects with metastatic colorectal cancer (mCRC) and acquired resistance to anti-epidermal growth factor receptor (EGFR) 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 Ib - 201-201101[/INST] The purpose of this study is to describe the safety and tolerability of two dose levels of OTO-201, placebo and sham when administered intra-operatively in pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This will be a Phase 1b/2a, exploratory, open-label study, in which up to 20 eligible ME patients will be enrolled at up to 5 clinical sites in the U.S. Twenty eyes of 20 patients will be enrolled which means that only one eye will be treated with study treatment in patients who present at Visit 1 with bilateral ME. In situations where both eyes of a patient are eligible for the study, the eye with the shorter duration of ME will be the study eye.9 The investigator will designate the study eye when both eligible eyes have been diagnosed with ME at the same time. Potential patients who are interested in participating in the study will be provided an informed consent form (ICF) prior to screening. Patient eligibility will be assessed at Visit 1 (Day 0), the baseline visit, by spectral SD-OCT and measurement of IOP, in addition to review of the patient's medical and ophthalmic history and recent concomitant medications history. Study Treatment will be administered on Day 0, Day 4, and Day 9 (Visits 1, 2, and 3). Subjects will be scheduled to return to the clinic for post-treatment assessments during Visits 4 and 5 (Day 14 and Day 21 or Day 28). [/INST] To evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution, EGP-437, using the EyeGate® II Drug Delivery System (EGDS) in patients with macular edema (ME) </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 (JP)[/INST] The purpose of this study is to assess safety, tolerability and pharmacokinetics of D5884 following administration of single and multiple doses in healthy male Japanese 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 II - CA180-085[/INST] The purpose of this study is to learn if men with metastatic prostate cancer and rising Prostate Specific Antigen (PSA), who have been surgically castrated or are undergoing androgen deprivation with Luteinizing Hormone Releasing Hormone (LHRH) treatment, respond to dasatinib. The safety of this treatment will also be studied. </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 - Dana Farber Cancer Institute[/INST] This research study is a Phase II clinical trial. Phase II clinical trials test the effectiveness of an investigational drug, PCI-32765, to learn whether PCI-32765 works in treating a specific cancer. "Investigational" means that PCI-32765 is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if PCI-32765 is effective for treating different types of cancer. It also means that the FDA has not yet approved PCI-32765 for use in patients, including people with Waldenstrom's Macroglobulinemia. PCI-32765 is a newly discovered drug that is being developed as an anti-cancer agent. PCI-32765 is a Bruton's tyrosine kinase (Btk) inhibitor drug which interrupts B cell receptor (BCR) signaling in lymphomas by selectively and irreversibly binding to the Btk protein, which then results in malignant cell death. This drug has been used in laboratory experiments and other research studies in B-cell malignancies and information from those other research studies suggests that PCI-32765 may be a treatment strategy for B-cell malignancies, including Waldenstrom's Macroglobulinemia. In this research study, the investigators are testing the safety and efficacy of PCI-32765 as a treatment option for relapsed or refractory Waldenstrom's Macroglobulinemia. </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 - PRO-811[/INST] Probuphine (buprenorphine implant) is an investigational implant placed just below the skin containing buprenorphine (BPN). BPN is an approved treatment for opioid dependence. This is a 6-month, open-label, re-treatment study that will confirm the safety and efficacy of Probuphine in patients who have previously completed the 6-month PRO-806 study with either Probuphine, placebo or sublingual buprenorphine. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This dose-escalation study will examine HLD100 in 24 subjects. The subjects (n=24) will be tested with HLD100 in ascending doses from 10mg up to 40mg. This study will be divided into several phases: Screening, Active Treatment and Follow-Up. All visits have a 2 day window to allow for scheduling. [/INST] The phase 2 study will evaluate the safety, tolerability and efficacy of HLD100 at steady state (following up to 5 weeks of treatment) in children using an outpatient, single-center, open-label, flexible dose-escalation study design. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This is a phase 2, multicenter, randomized, double blind (with dose), placebo controlled, parallel group, proof of concept, and dose range finding study to evaluate the efficacy, safety, and PK of X0002 spray in adult subjects with clinically symptomatic mild to moderate OA of the knee. After a screening period of up to 3 weeks and radiographic evaluation of the target knee joint space, 225 subjects will be randomly assigned to 1 of 3 treatment groups in a 1:1:1 ratio with a 2:1 ratio of active:placebo within each treatment group in a 1:1:1 ratio with a 2:1 ratio of active:placebo within each treatment group (i.e., 2 subjects to active treatment and 1 subject to placebo): Group A: low dose of X0002, twice daily (BID, approximately every 12 hours; n=50) or placebo (low dose), BID (approximately every 12 hours; n=25); Group B: middle dose of X0002, BID (approximately every 12 hours; n=50) or placebo , BID (approximately every 12 hours; n=25) ; Group C: High dose of X0002, BID (approximately every 12 hours; n=50) or placebo, BID (approximately every 12 hours; n=25) . Safety and efficacy assessments will be performed at at 2, 4, 8, and 12 weeks of treatment. [/INST] This is a phase 2, multicenter, randomized, double blind (with dose), placebo controlled, parallel group, proof of concept, and dose range finding study to evaluate the efficacy, safety, and PK of X0002 spray in adult subjects with clinically symptomatic mild to moderate OA of the knee. Objectives of the study: 1. To evaluate the efficacy of X0002 spray compared to placebo for relief of knee pain in subjects with osteoarthritis (OA) of the knee; 2. To assess the safety and tolerability of multiple doses of X0002 when administered as a topical spray. </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 - AUBURN[/INST] Study of the Efficacy, Safety & Tolerability of Serlopitant for Pruritus (Itch) After Burn Injury </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> The study will enroll approximately 375 subjects randomized 1:1:1 to dose regimens of 180µg, 120µg BXCL501, or placebo. Male and female adults with acute agitation associated with schizophrenia, schizoaffective disorder, or schizophreniform disorder will be enrolled. Eligible subjects may be identified in outpatient clinics, mental health, psychiatric or medical emergency services including medical/psychiatric observation units, or as newly admitted to a hospital setting for acute agitation or already in hospital for chronic underlying conditions. Subjects will be domiciled in a clinical research setting or hospitalized to remain under medical supervision while undergoing screening procedures to assess eligibility. Efficacy and safety assessments will be conducted periodically before and after dosing. [/INST] This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in schizophrenia. The BXCL501-301 study is designed to characterize the efficacy, safety and tolerability of BXCL501 (sublingual film formulation of DEX, HCl) in agitation associated with schizophrenia, schizoaffective disorder or schizophreniform disorder. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> Randomized, double-masked, vehicle-controlled, phase 2 study evaluating the efficacy and safety of OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of signs and symptoms of Dry Eye Disease (DED). The subjects will be followed for approximately 2-3 months from screening to the last visit. [/INST] To assess the efficacy and safety of OTX-DED for the short-term treatment of signs and symptoms of dry eye disease. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> GSK2140944 belongs to the Bacterial Type II Topoisomerase Inhibitor (BTI) class of antibiotics. GSK2140944 has demonstrated in vitro and in vivo activity against Gram positive pathogens including methicillin resistant Staphylococcus aureus (MRSA) and Gram-negative pathogens associated with respiratory tract, skin and soft issue infections including isolates resistant to existing classes of antimicrobials. This study will be the first administration of GSK2140944 as an intravenous (IV) formulation in humans and will be conducted in two (2) parts. Single IV doses will be explored in Part A and repeat IV doses will be explored in Part B. In addition, this study will evaluate the absolute bioavailability of an oral capsule formulation as compared to the IV formulation in Part A. Both study parts will investigate the safety, tolerability and pharmacokinetic profile of GSK2140944 in healthy adult subjects. [/INST] GSK2140944 belongs to the Bacterial Type II Topoisomerase Inhibitor (BTI) class of antibiotics. GSK2140944 has demonstrated in vitro and in vivo activity against Gram positive pathogens including methicillin resistant Staphylococcus aureus (MRSA) and Gram-negative pathogens associated with respiratory tract, skin and soft tissue infections including isolates resistant to existing classes of antimicrobials. </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] Exploratory, multi-center, randomised, investigator-blinded, vehicle controlled study using intra-individual comparison involving subjects with acne vulgaris on face to evaluate the efficacy of CD5024 1% cream over a 6-week treatment period compared to its vehicle. </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 - Israel[/INST] This study evaluates the safety and efficacy of intravenous GLASSIA® treatment in lung 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 I - Dose Escalation[/INST] The primary objective of the study is to assess the safety of IV administration of rIX-FP. Safety will be evaluated by adverse events and laboratory changes over time. The secondary objective of the study is to evaluate the pharmacokinetics parameters, following a single intravenous dose of rIX-FP. </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 - DIUR-005[/INST] This study is a parallel arm, randomised, open-label study, including dose titration and admissions for four overnight stays for 24-hour endocrine profiles. It will compare the efficacy, safety and tolerability of Chronocort® with standard glucocorticoid replacement therapy in the treatment of congenital adrenal hyperplasia (CAH) over a treatment period of 6 months. Dose titration decisions in both treatment groups will be made by a central independent physician, blinded to the treatment arm, using information generated from the 24-hour endocrine profiles. Each treatment arm will be subject to the same titration rules throughout the study, ensuring that opportunities for optimisation and control of androgens are the same in both groups. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> The treatment period starts with a 12-week, double-blind, placebo-controlled, randomized period followed by an open-label extension phase. In the double-blind phase, eligible patients are randomized (4:1 ratio) to receive either certolizumab pegol (CZP) or Placebo up to and including Week 10. The randomization will be stratified according to the three factors: concomitant use of methotrexate (MTX, Yes or No), prior anti-tumor necrosis factor (anti-TNF) use (Yes or No), and disease duration categories (< 2 years or ≥ 2 years). From Week 12 all patients remaining in the study receive open-label CZP for a minimum 16 additional weeks until CZP is commercially available. [/INST] This is a Phase IIIb multicenter study to evaluate the safety and efficacy of certolizumab pegol (CZP) administered to patients with moderate-to-severe rheumatoid arthritis. </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 - CAR-BHA-I21[/INST] This clinical study is being conducted to demonstrate the safety and effectiveness of the Bone Healing Accelerant (BHA) product when applied to tibia (leg bone) fractures with an external wound or skin break (also called open tibia fractures). It is hypothesized that by 6 months, the number of subjects with successful bone healing will be greater in the BHA-treated group compared to subjects treated with standard of care alone. Open tibia fractures were chosen for this study because healing rates are typically longer than for other bone fractures due to the limited vascular supply, limited soft tissue coverage, and higher risk of 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 II - Peripheral Nerve Injury[/INST] This study will be a double-blind, placebo-controlled, parallel group study. After enrolment and initial assessments, subjects will receive oral GW856553 7.5 milligram (mg) twice daily (BID) or matching placebo for 28 days in a 1:1 ratio. Sufficient numbers of subjects will be recruited to obtain 142 evaluable subjects. This is a double-blind, randomized, placebo-controlled, parallel group study. Subjects will undertake a screening period which may last up to approximately 3 weeks, followed by a baseline period of 1 week, a randomized treatment period of 4 weeks and a follow-up period of approximately 2 weeks. This is a multi-centre, double-blind, randomized, placebo-controlled study in subjects who have at least moderate intensity of neuropathic pain resulting from peripheral nerve injury due to trauma or surgery. It will investigate the efficacy, safety and tolerability of GW856553 over 28 days of treatment. Approximately 158 subjects will be randomized to ensure 142 evaluable subjects. Randomization ratio will be 1:1 for placebo or GW856553 respectively. The dose of GW856553 will be 7.5 mg BID. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> The study is a single-centre, double-blind, randomized, placebo-controlled, parallel group phase I study with healthy male subjects receiving ascending multiple oral oral doses of Px-102 to assess the safety and tolerability, pharmacokinetics and pharmacodynamics. [/INST] The purpose of this study is to assess the safety and tolerability of the FXR agonist Px-102 in healthy subjects after 7 days multiple oral dosing. </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 - CANTATA-D (vs. Sitagliptin)[/INST] The purpose of this study is to evaluate the efficacy and safety of canagliflozin compared with sitagliptin and placebo in patients with type 2 diabetes mellitus who are receiving treatment with metformin monotherapy (i.e., treatment with a single drug) and have inadequate glycemic (blood sugar) control. </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 - RESTART[/INST] The purpose of this study is to assess the effectiveness of treatment in patients with active rheumatoid arthritis who are having an inadequate response to at least 3 months of treatment with etanercept or adalimumab in addition to methotrexate. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> NOTE: Detailed Description : data not entered [/INST] Optional open label, roll over extension study to investigate the efficacy and safety of secukinumab treatment in Juvenile Idiopathic Arthritis (JIA) subtypes of Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA). </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 study designed to investigate the safety, tolerability, PK and PD of intravenously administered AL001 in Healthy Volunteers and FTD-GRN mutation carriers. [/INST] A first in human phase 1 study in healthy volunteers and participants with Granulin (GRN) mutation causative of frontotemporal dementia (FTD) to assess AL001 safety, tolerability, pharmacokinetics, and pharmacodynamics </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> EYN-1601 delivered topically as a microdose via a proprietary delivery system (the Eyenovia Multi-Dose Device [MDD] system) is being investigated for dilation of the pupil for ophthalmic examinations and procedures. Phenylephrine hydrochloride, a sympathetic α1-adrenergic agonist, has been used for pupil dilation for over 70 years. The mydriatic action of phenylephrine is due to its stimulation of the α1 receptors of the radial muscle of the iris, which causes the muscle fibers to contract and results in pupil dilation. When conducting a variety of ophthalmological procedures, it is necessary to dilate (enlarge) the pupil to allow an unobstructed view of the lens and retina, as well as the optic nerve. The degree of pupil dilation required is somewhat dependent on the procedure being performed. Eyenovia, the Sponsor, is a specialty pharmaceutical company focused on the development of ophthalmic drug products that can be delivered in small volumes, ie, via microdosing, in order to maximize therapeutic control and minimize systemic absorption. To achieve this goal, Eyenovia is developing a drug/device combination product to allow accurate topical ocular delivery of controlled quantities of specific active pharmaceutical ingredients. Phenylephrine has been known to cause systemic cardiovascular effects in some patients when dosed via the topical ocular route including hypertension, tachycardia, and more rarely, arrhythmia and stroke, especially in those patients with pre-existing heart conditions. These risks are even more relevant when phenylephrine hydrochloride ophthalmic solution 10% is used in circumstances where a greater degree of mydriasis is required. Microdosing with the Eyenovia MDD system is expected to significantly reduce or eliminate these risks while allowing the same degree of mydriasis produced with the currently approved products. Subjects (healthy volunteers) will be screened for eligibility and 12 subjects that meet inclusion/exclusion criteria will be enrolled into the study. All subjects will be followed through the same pre-specified treatment visit schedule at which the 3 study drugs are administered (phenylephrine 2.5% eyedrops at Visit 1, phenylephrine 10% eyedrops at Visit 2 and EYN-1601 MDD at Visit 3). At each treatment visit, baseline measurements will be taken prior to study medication administration. Subjects will participate in safety, efficacy, and pharmacokinetic assessments. Subsequent visits must be separated by at least 2 days but may be up to 1 week apart. Efficacy will be assessed by measurement of pupil dilation in both eyes. Safety assessments will include slit lamp examination (SLE) of both eyes and measurement of vital signs (blood pressure [BP]/heart rate [HR]) and adverse events, as well as an ocular discomfort survey Absorption will be assessed through blood plasma analysis to detect free phenylephrine. [/INST] This is a Phase 2 study to investigate the safety, efficacy and pharmacokinetics of EYN-1601 for dilation of the pupil. A single microdose of EYN-1601 will be compared to single doses of commercially available phenylephrine hydrochloride 2.5% and 10% ophthalmic solutions. </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 - Androgenetic Alopecia[/INST] This study will evaluate the safety, tolerability and efficacy of the oral administration of setipiprant tablets 1000 mg twice daily (BID) relative to placebo in 18 to 49 years old males with androgenetic alopecia (AGA). </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 - HER2-[/INST] The purpose of this trial is to evaluate the efficacy, safety and pharmacokinetics of BIBW 2992, a dual, irreversible EGFR- and HER2-inhibitor, in two cohorts of patients with HER2-negative breast cancer after failure of no more than three regimen of prior chemotherapy. </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 - PREDICT 2X-121[/INST] This study is to be performed as an open label, multicenter, single arm study of 2X-121 to evaluate anti-tumor efficacy of 2X-121 as single agent therapy in a 28-days cycle in advanced ovarian cancer patients. 2X-121 will be supplied for oral administration once daily as 600 mg (3 x 200 mg) capsules in a 28 days cycle. Patients with predicted high likelihood of responding to the drug (2X-121) using drug response prediction (DRP®), will be included in the study. </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 orteronel. Orteronel is being tested to treat adult males who have adenocarcinoma of the prostate. This study will look at the pharmacokinetics (how the drug moves through the body) and pharmacodynamics (how the drug effects the body) in people who take orteronel in addition to prednisone. The study will enroll approximately 144 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the eight treatment groups (4 in Japan, 4 in Ex-Japan) which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need). In Japan: Participants were randomized in a ratio of 2:1:2:1 - 200 mg orteronel or Placebo-matching orteronel [(dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient] twice daily (BID) + prednisone - 300 mg orteronel, or Placebo-matching orteronel, BID + prednisone Ex-Japan Participants were randomized in a ratio of 2:1:2:1 - 200 mg orteronel or Placebo-matching orteronel, BID in Cycle 1 + prednisone - 400 mg orteronel, or Placebo-matching orteronel ,BID in Cycle 1 + Prednisone Participants initially randomized to placebo received 4 weeks of placebo and then 12 weeks of active treatment with orteronel then entered a follow-up period treatment period. Participants initially randomized to orteronel received 16 weeks of treatment then entered a follow-up treatment period. This multi-centre trial will be conducted worldwide. The overall time to participate in this study is approximately 3.2 years. Participants will make multiple visits to the clinic and a final visit 30 to 40 days after receiving their last dose of study drug for a follow-up assessment. [/INST] This is a double-blind, placebo-controlled, multiregional Phase1/2 study to characterize the pharmacokinetic and pharmacodynamic responses to orteronel when administered concomitantly with prednisone in Chemotherapy-Naive Participants With Castration-Resistant Prostate 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 IIa - Functional Dyspepsia (EU)[/INST] The objectives of this study are to determine the safety and efficacy of IW-9179 administered to patients with functional dyspepsia (FD). </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 - ADG116-1003[/INST] This is a Phase 1, open-label, dose escalation study in patients with advanced/metastatic solid tumors. Study drug, ADG116, is an anti -CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. ADG106, a fully human ligand-blocking agonistic anti-CD137 IgG4 mAb, is expected to enhance the activity of activated T cells. The enhanced antitumor efficacy results observed from the preclinical studies of ADG116 in combination with ADG106 or anti-PD-1 provided further support to explore such combinations in clinical settings for better patient responses. </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/mFOLFOX6 (Asia) (HER2-)[/INST] This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with mFOLFOX6 in patients with metastatic HER2-negative adenocarcinoma of the stomach or gastroesophageal junction. Patients will be randomized in a 1:1 ratio to receive either onartuzumab (MetMAb) or placebo in combination with mFOLFOX6. Patients may continue to receive onartuzumab (MetMAb) or placebo until disease progression, unacceptable toxicity, patient or physician decision to discontinue 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 IIIb - ANDHI[/INST] The purpose of this study is to investigate the effect of benralizumab on the rate of asthma exacerbations, patient reported quality of life and lung function during the 24-week treatment in patients with uncontrolled, severe asthma with an eosinophilic phenotype. A subset of patients will be assessed for their ongoing chronic rhinosinusitis with nasal polyps. The study design has been updated to include a 56-week open label ANDHI in Practice (ANDHI IP) sub study upon the completion of the 24-week double-blind period of the ANDHI 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 II - w/Atezolizumab[/INST] This is a Phase II, multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of MOXR0916 in combination with atezolizumab versus placebo and atezolizumab in participants with locally advanced or metastatic urothelial carcinoma (UC) who have not received prior systemic therapy in the locally advanced/metastatic setting and who are ineligible to receive cisplatin-based therapy. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> Eligible subjects with written informed consent will be stratified according to their baseline HCV RNA (≤800,000 IU/mL versus>800,000 IU/mL), stage of liver fibrosis (METAVIR system fibrosis score of 0 1 versus 2 3). During the 48 week Treatment Period and 24 week Follow up Period, subjects will be assessed at regular intervals for efficacy and safety at Weeks 2, 4, 8, 12, 16 and then every 8 weeks thereafter until study completion. If possible, subjects who prematurely discontinue the study during the Treatment Period will have samples taken for hematology, biochemistry and urinalysis in the same week of discontinuation as well as 24 weeks after discontinuation. [/INST] This is a randomized, double blind, multi-center, placebo controlled, three parallel arms, Phase IIb/III clinical study to evaluate the effects of adding a TCM-700C with a low or high dose onto the combination treatment (PegIFN plus RBV) for subjects with naive genotype 1 HCV infection. This will be demonstrated by a higher sustained virologic response rate, defined as the absence of detectable HCV RNA 24 weeks after the termination of combination treatment, compared with the placebo add-on. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This is a double-blind, double-dummy, active-comparator study of LT-NS001 versus Naprosyn® for 12 weeks in patients aged 45-80 with osteoarthritis of the knee who are candidates for ongoing NSAID therapy. The percentage of patients with a gastric ulcer by endoscopy (EGD) at week 12 will be compared. EGD is performed at screening and months 1, 2, and 3. Secondary objectives include assessment of pain in the affected knee by WOMAC questionnaire to demonstrate non-inferior pain control using LT-NS001 as compared to Naprosyn®. Information about gastrointestinal pain and tolerability will be collected. The length of the study is up to 19 weeks with a 2-3 week screening period, a 12 week treatment period and a 4 week post treatment monitoring period. [/INST] LT-NS001 is a prodrug of Naproxen, which is inactive as a cox inhibitor while intact and is rapidly metabolized to Naproxen once absorbed. This trial will compare the rate of gastric ulcer by endoscopy over three months in patients with knee osteoarthritis, with patients receiving either LT-NS001 at a dose which provides comparable dose levels of Naproxen, or Naprosyn® 500mg (an approved treatment for OA). </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This study was an open-label, single administration design, conducted in male and female patients ≥40 years of age with OA of the knee. Patients were enrolled sequentially with 8 patients per cohort, as follows: Cohort A: FX006 40 mg, Final Visit at Week 20 Cohort B: FX006 40 mg, Final Visit at Week 16 Cohort C: FX006 10 mg, Final Visit at Week 12 Cohort D: FX006 40 mg, Final Visit at Week 12 Cohort E: Triamcinolone acetonide immediate-release (TCA IR) 40 mg, Final Visit Week 12 Each patient was evaluated for up to 12, 16, or 20 weeks following a single IA injection depending on the assigned cohort. Following the screening visit, safety was evaluated at 3 out-patient visits and synovial fluid was collected at Day 1 for baseline measurements and the Final Visit for drug concentration measurements. [/INST] The purpose of this study was to characterize the local duration of exposure of TCA for 2 doses of FX006 relative to 40 mg of TCA IR in patients with OA of the knee. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> Fludarabine is a chemotherapy drug that is approved for the treatment of patients with Chronic Lymphocytic Leukemia (CLL). Cyclophosphamide is also a chemotherapy drug that is commonly used to treat patients with CLL. Rituximab and alemtuzumab are special proteins (antibodies) that specifically target and attach to proteins on leukemia cells. These targeted proteins may also be present on normal blood cells. When these antibodies bind to the proteins on leukemia cells, they may help to stop or slow the growth of the disease. The combination of fludarabine, cyclophosphamide, and rituximab has been used in the treatment of previously untreated patients with CLL. The purpose of this study is to see if there is added benefit with the addition of alemtuzumab to this combination. Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in the study. You will have a complete physical exam, including routine blood tests (about 3 tablespoons). You may have either a chest x-ray or a computerized tomography (CT) scan if your doctor thinks it is necessary. If you have not had a bone marrow biopsy collected in the past 4 months, you will have a bone marrow sample collected at this time. To collect a bone marrow biopsy, an area of the hip or chest bone is numbed with anaesthetic, and a small amount of bone marrow is withdrawn through a large needle. Women who are able to have children must have a negative blood or urine pregnancy test. If you are found to be eligible to take part in this study, you may begin treatment. During this study, you will have up to 6 "cycles" of treatment. A cycle is made up of treatment with the study drugs for 5 days in a row, then around 3 and a half weeks (23 days) of no treatment with the study drugs. On Days 1, 3, and 5 of each cycle, you will receive alemtuzumab through a needle in a vein. On Day 2 of each cycle you will receive rituximab through a needle in a vein. Cyclophosphamide and fludarabine will be given separately on Days 3, 4, and 5 of each cycle through a needle in a vein. In addition to the study drugs, you may also be given premedication and fluids by vein to help decrease the risk of side effects. The premedication may include steroids that are used to decrease the risk of side effects from the alemtuzumab and rituximab. They will be given before each dose of the alemtuzumab and rituximab. The infusions for each daily treatment visit should take less than 6 hours. This treatment will be given on an outpatient basis. The combination treatment will be repeated every 4 weeks (1 cycle) for a total of up to 6 cycles. You will receive acetaminophen (Tylenol) by mouth and diphenhydramine hydrochloride (Benadryl) by mouth or vein 30-60 minutes before each dose of rituximab and alemtuzumab. You will also receive hydrocortisone (a steroid) by vein before the first dose of alemtuzumab of each cycle. These drugs will be used to help decrease the risk of side effects. If side effects occur during a treatment, the doses of the drugs may be adjusted (up or down) until the symptoms are gone. Also, if you experience side effects during treatment, you must stay in the clinic to be observed, for 2 hours after the drug is given. During the treatment and for 2 months after completion of treatment, you will need to take antibiotics to decrease the risk of developing infection. Trimethoprim/sulfamethoxazole (Bactrim DS, SMX) is a sulfa-drug, and you will be given this to decrease the risk of a type of pneumonia called PCP pneumonia. If you are allergic to sulfa drugs, a similar antibiotic may be given. You will take Valtrex to decrease the risk of potential virus reactivation, including herpes. If you are allergic to Valtrex, a similar antibiotic may be given. You may receive an antibiotic called valganciclovir (Valcyte) to decrease the risk of another virus called cytomegalovirus. You may also take allopurinol for the first week of the first course of treatment. This will help decrease the risk of kidney damage from rapid destruction of your leukemia cells. During the Cycle 1 of treatment, you will have blood drawn (about 2 tablespoons) for routine blood tests once a week. Then, these blood tests will be repeated before the start of each additional cycle (every 4 weeks). You will also see your treating doctor and provide a history and have a routine physical exam done before each cycle of treatment. After 3 cycles of treatment, you will have a physical exam and routine blood tests (about 2 tablespoons). You may also have either an x-ray or a CT scan. You will have another bone marrow sample collected. These tests will be used to see if the disease is responding to treatment. If it is found that the disease is not responding to treatment after the first 3 cycles of therapy, you will be taken off the study, and your doctor will discuss other treatment options with you. If it is found that the disease is responding to treatment, another 3 cycles (12 weeks) of treatment will be given. During these additional 3 cycles of therapy, you will have blood drawn (about 2 tablespoons) once a week for routine blood tests. After 6 cycles of treatment, you will have a physical exam, around 2 tablespoons of blood drawn for routine blood tests, and a bone marrow aspirate and biopsy to determine if your leukemia is in remission. If your disease gets worse or you experience any intolerable side effects, you will be taken off the study, and your doctor will discuss other treatment options with you. Around 3-6 months after you receive your last treatment cycle, you will have a physical exam and routine blood tests (about 2 tablespoons). After that, you will have a physical exam and routine blood tests (about 2 tablespoons) every 6 months for the next 2 years. If the leukemia has gone into remission, you will have a bone marrow aspirate and biopsy at 6 months, 1 year, and 2 years after your last treatment cycle, to make sure it stayed in remission. If your disease returns or if you start a new therapy, you will not need to return for these visits. However, you should inform the study doctor/staff that you are receiving other treatment. This is an investigational study. All of the drugs used in the study are FDA approved and commercially available. Their use together in this study, however, is experimental. As many as 60 patients will take part in the study. All will be enrolled at M.D. Anderson. [/INST] Primary Objective: 1. Evaluate the ability of Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR) to increase the proportion of patients with <5% CD5/CD19+ cells in bone marrow to 66% following 3 courses of treatment without significantly increasing the incidence of pneumonia or sepsis compared to a historic group of patients treated with the combination fludarabine, cyclophosphamide, and rituximab (FCR). Second Objectives: 1. Assess complete remission (CR), nodular partial remission (nPR), and partial remission (PR) rates (overall response) in high-risk, previously untreated patients with CLL treated with CFAR. 2. Evaluate molecular remission in bone marrow by polymerase chain reaction (PCR) for the clonal immunoglobulin heavy chain variable gene in responders treated with CFAR. 3. Assess immune parameters including blood T cell counts and subset distribution and serum immunoglobulin levels pretreatment, during treatment, and post-treatment in patients treated with CFAR. </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 - 0123 (w/Bendamustine/Rituximab; Previously Untreated)[/INST] The primary objective of this study is to evaluate the progression-free survival in participants with previously untreated chronic lymphocytic leukemia (CLL) who would otherwise be suitable for bendamustine and rituximab treatment as standard of care. An increased rate of deaths and serious adverse events (SAEs) among participants with front-line CLL and early-line indolent non-Hodgkin lymphoma (iNHL) treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA). </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> Progerias are rare "premature aging" diseases in which children die of severe atherosclerosis leading to strokes and heart attacks. It is a multisystem disease with objective clinical markers for disease progression. These include abnormalities in growth and body composition, bone mineral density, join function, endocrine function, alopecia, and vascular disease. There is currently no therapy proven effective for any of the progressive and deleterious aspects of this disorder. Progeria is caused by a gene defect in the gene LMNA, coding for the nuclear protein lamin A. Lamin A is normally expressed by most differentiated cells, and requires posttranslational farnesylation to incorporate into the nuclear membrane. This trial proposes to use three agents (zoledronic acid, pravastatin, and lonafarnib) to inhibit farnesylation of abnormal lamin, the disease causing protein in Progeria. The primary objective of this study is to evaluate the feasibility of administering intravenous zoledronic acid, oral pravastatin and oral lonafarnib, to patients wtih Progeria for a minimum of 4 weeks. [/INST] This is an open label single arm feasibility trial. A combination of two oral agents (pravastatin and lonafarnib) and one intravenous (IV) agent (zoledronic acid) will be administered at doses and schedule currently applied in pediatrics. These agents all target farnesylation pathways at different points. Our goal is to inhibit farnesylation of abnormal lamin, the disease-causing protein in Hutchinson-Gilford Progeria Syndrome and progeroid laminopathies (henceforth "progeria"). The drugs will include the intravenous bisphosphonate zoledronic acid, oral HMG co-reductase inhibitor pravastatin and the oral farnesyltransferase inhibitor (FTI) lonafarnib (SCH 66336). Patients with genetically confirmed progeria will be eligible for this protocol. Treatment will be initiated for 4 weeks duration and may be extended depending on tolerability. This study will assess the feasibility of this treatment regimen in the first 4 weeks. If tolerated for 4 weeks, patients can be treated with this regimen for up to 6 months. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> Site initiation visit of the study site, InVentiv Health Clinique, Inc. by on-site visit and teleconference was done and the final report signed 21st July 2017. For the demographic and baseline characteristics descriptive statistics consisting of mean, median, standard deviation, minimum, maximum and sample size is reported for continuous variables like age, body mass index, weight and height. categorical variables like ethnicity, gender and race is presented as frequency counts and percentages. For PK analysis, Steady state concentration level of leuprolide calculated for oral tablets (Treatments A and B) at the end of the fourth treatment week (Treatment Days 28) as the 24-hour AUCs divided by the duration of the dosing interval i.e., 24 hours. For PD analysis, subject incidence of estradiol level below 40 pg/mL was assessed. The ovulation rate determined by the extent of progesterone suppression is presented. Only observed data is used in the data analysis except for concentration values below the lower limit of quantitation (BLQ) and samples with no reportable value occurring prior to dosing (on Day 1 only). No attempt is made to impute (i.e., extrapolate or interpolate) estimates for missing data. For safety analysis, incidence of treatment emergent adverse events both during the dosing and post dosing period is presented. The Medical Dictionary for Regulatory Activities (MedDRA®) Version 20.1 is used to classify all medical history findings and incidences of treatment emergent adverse events (TEAE) reported during the study by System Organ Class (SOC) and Preferred Term (PT). [/INST] This Phase 2a, pharmacokinetic/pharmacodynamic study will determine the safety and provide evaluation of the PK/PD metrics of three different oral doses selected upon the results of the study LOPDT-PH1-01 - 4 mg oral tablets administered over 28 days as QD and BID regimens and 10 mg oral tablets administered over 28 days as a BID regimen. The PK/PD profiles of the study drug will be compared to the leuprolide formulation approved for the treatment of endometriosis (a monthly intramuscular injection, Lupron Depot 3.75 mg). Major PK (e.g., a total exposure to leuprolide) and PD parameters (e.g., rates of the estradiol suppression and cessation of the menstrual period) will also be evaluated against the Lupron Depot historical data. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> A phase 2a proof-of-concept, randomised, double-blind, placebo-controlled study to evaluate the safety/tolerability and efficacy of 4 subcutaneous injections of namilumab (150 mg) given over 10 weeks in subjects with moderate-to-severely active axial spondyloarthritis including those previously exposed to anti- TNF therapy (NAMASTE study). [/INST] The study will assess the effect of namilumab, a GM-CSF inhibitor, on the clinical response in subjects with axial spondyloarthritis. Subjects will receive treatment with either namilumab or 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 I - D0110C00005[/INST] Purpose of this study is to assess the safety and tolerability of AZD5438 given orally to patients with advanced solid malignancies A review of the emerging clinical tolerability and exposure data from this study in conjunction with preclinical and the available clinical pharmacodynamic data relating to AZD5438, led to a decision by AstraZeneca that the development of AZD5438 as a potential anti-cancer agent would 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 I - SAD/MAD (AROAPOC31001)[/INST] The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple doses of ARO-APOC3 in healthy adult volunteers and in patients with severe hypertriglyceridemia and familial chylomicronemia syndrome (FCS). </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 - 1218.75 (Black/African American)[/INST] Study of linagliptin vs. placebo in Black/African American patients with T2DM with a MTT sub-study </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> PRIMARY OBJECTIVES: I. To compare central review-based progression-free survival in poor prognosis carcinoid patients treated with either depot octreotide (octreotide acetate) plus bevacizumab, or depot octreotide plus interferon (recombinant interferon alfa-2b). SECONDARY OBJECTIVES: I. To compare overall survival, time to treatment failure and traditionally reported progression-free survival in poor prognosis carcinoid patients treated with either depot octreotide plus bevacizumab, or depot octreotide plus interferon. II. To compare objective response (confirmed and unconfirmed complete response [CR] and partial response [PR]) in poor prognosis carcinoid patients treated with either depot octreotide plus bevacizumab, or depot octreotide plus interferon. III. To compare the toxicity profile of patients treated with these two regimens. TERTIARY OBJECTIVES: I. To assess the prognostic and predictive value of vascular endothelial growth factor (VEGF) expression in relation to progression-free survival and treatment effect. II. To compare response of 5HIAA, chromogranin A and neuronspecific enolase among patients with elevated levels at baseline between patients treated with octreotide plus interferon versus octreotide plus bevacizumab. III. To assess and compare the prognostic and predictive value of the combination of In-111 pentetreotide somatostatin-receptor scintigraphy (SRS) and computed tomography (CT) vs. CT in relation to progression-free survival (PFS). IV. To assess and compare the prognostic and predictive value of the combination of SRS and CT vs. CT in relation to overall survival (OS) and time to treatment failure (TTF). OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive octreotide acetate intramuscularly (IM) and bevacizumab intravenously (IV) over 30-90 minutes on day 1. ARM II: Patients receive octreotide acetate IM on day 1 and recombinant interferon alfa-2b subcutaneously (SC) on days 1, 3, 5, 8, 10, 12, 15, 17, and 19. Treatment in both arms repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 2-6 months for up to 3 years. [/INST] This randomized phase III trial studies octreotide acetate and recombinant interferon alfa-2b to see how well it works compared to octreotide acetate and bevacizumab in treating patients with high-risk neuroendocrine tumors that have spread to other places in the body (metastatic) or spread from where it started to nearby tissue or lymph nodes (locally advanced). Octreotide acetate and recombinant interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of cancer. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving octreotide acetate together with recombinant interferon alfa-2b is more effective than giving octreotide acetate together with bevacizumab in treating patients with neuroendocrine tumor. </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 - HDM-induced [/INST] This study is a Phase IIa, randomized, placebo-controlled, double-blind, 2-way crossover, 2-center (conducted in EU; The Netherlands) study in male and female subjects with stable, mild HDM-allergic asthma. The study will consist of two identical study periods of 12 treatment days each, separated by a washout period of at least 3 weeks (and no more than 7 weeks). Approximately 36 eligible subjects will be enrolled, to yield 32 evaluable subjects who will be treated with both FP-025 (400 mg BID) or matching placebo in a cross-over design from the evening of Day 1 till the morning of Day 12 (22 doses per study period in total). </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 - Different Formulations[/INST] The main purposes of this study are: 1. To learn more about the safety and side effects of different formulations of LY3375880 and 2. To measure how much LY3375880 gets into the blood stream and how long it takes to get out of the body. The study will last about 85 days. Screening may occur up to 28 days prior to enrollment. </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 - 015 (w/Rosuvastatin)[/INST] The study is to assess the effect of coadministration of multiple doses of BMS-986165 on the systemic exposure of rosuvastatin in healthy participants. </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 - MYSTIC[/INST] The objective of this study is to evaluate the chronic safety and effectiveness of OC-01 Nasal Spray as compared to placebo on signs of dry eye disease (DED). </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 (all people know which treatment the participants receive) Phase 2 study to investigate the efficacy, safety and pharmacokinetics of simeprevir, daclatasvir and sofosbuvir in treatment-naive (participants have never received HCV treatment with any approved or investigational agent) and treatment - experienced (participants have failed at least one previous course of [Pegylated] interferon [(Peg)IFN], with or without Ribavirin) participants. Participants will be assigned to 1 of 2 panels: Panel 1 (n=20): Child-Pugh score less than (<) 7 with evidence of portal hypertension (confirmed by presence of esophageal varices or HVPG greater than or equal to [>=] 10 mm Hg); Panel 2 (n=20): Child-Pugh score 7 to 9 (extremes included). The total study duration for each participant will be approximately 276 weeks. The study will consist of 3 parts: Screening Phase (approximately 4 weeks) and open-label treatment Phase (from Week 4 to 16) and follow-up Phase (until 5 years after the actual end of study drug treatment). Participants will receive simeprevir (150 milligram [mg] capsule), daclatasvir (60 mg tablet) and sofosbuvir (400 mg tablet) orally once daily for 12 weeks. Efficacy will be primarily evaluated by percentage of participants with SVR12. Participants' safety will be monitored throughout the study. [/INST] The purpose of this study is to assess the efficacy of a 12-week regimen containing simeprevir, daclatasvir and sofosbuvir in participants with decompensated liver disease (the liver function is insufficient) due to genotype 1 or 4 Hepatitis (inflammation of the liver) C virus (HCV) infection by assessing sustained virologic response 12-weeks after the end of study drug treatment (SVR12). </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> OBJECTIVES: Primary - To assess the complete cytogenetic response rate at 12 months in patients with Philadelphia chromosome- and BCR-ABL-positive early chronic phase chronic myelogenous leukemia treated with nilotinib and imatinib mesylate. Secondary - To assess the complete cytogenetic response rate at 6 and 24 months in these patients. - To assess the major and complete molecular response rate at 6, 12, and 24 months in these patients. - To assess the frequency and the types of BCR-ABL kinase domain mutations at 24 months during and for 3 years after study treatment. - To assess the rate of failures and the time to failure at 12, 24, and 60 months in these patients. - To assess compliance, toxicity, and adverse events in these patients. - To understand the relationship between response, gene expression profile, biomarkers, and drug plasma concentrations in these patients. OUTLINE: This is a multicenter study. Patients receive oral nilotinib twice daily in months 1-3, 7-9, 13-15, and 19-21 and oral imatinib mesylate once daily in months 4-6, 10-12, 16-18, and 22-24. Treatment continues for 24 months in the absence of disease progression or unacceptable toxicity. Patients may be eligible to continue oral nilotinib and oral imatinib mesylate for up to another 36 months if it is in the interest of the patient. Blood samples and bone marrow biopsies are collected periodically for cytogenetic response by chromosome banding analysis and FISH analysis; real-time quantitative PCR mutational analysis and single nucleotide polymorphism analysis of BCR-ABL transcripts; and gene expression profiling and correlative biomarker studies. After completion of study therapy, patients are followed every 6 months for 3 years and then every 12 months for 5 years. [/INST] RATIONALE: Nilotinib and imatinib mesylate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase II trial is studying how well giving nilotinib together with imatinib mesylate works in treating patients with early chronic phase chronic myelogenous leukemia. </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 - w/Ramucirumab (Advanced Cancer)[/INST] The purpose of this study is to find a recommended schedule and dose range for Emibetuzumab when given with ramucirumab that may be safely given to participants with cancer. In Part A of this study, escalating doses of Emibetuzumab will be given in combination with a fixed dose of ramucirumab to evaluate the safety of the combination. After a recommended schedule and dose range of Emibetuzumab and ramucirumab has been established, Part B of the study will confirm safety and to see how well certain tumors respond to the combination of study drugs. The average amount of time on study is expected to be about 6 months. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> Ragweed MATAMPL has been developed by Allergy Therapeutics to provide pre-seasonal specific immunotherapy for patients with proven type I hypersensitivity to cross reacting ragweed pollens causing rhinitis and/or conjunctivitis with or without mild to moderate asthma bronchiale. An earlier formulation of Ragweed MATAMPL developed by Allergy Therapeutics (UK), Ltd, available commercially in Canada since the 1980's, is 'Pollinex®-R'. 'Pollinex®-R' is formulated with modified allergens (allergoids) of ragweed pollen extract adsorbed onto L tyrosine at 4% w/v. Related formulations developed by ATL, available commercially in selected European countries since the 1970´s on a Named Patient Basis, are 'Pollinex Tree', 'Pollinex Grass', 'Pollinex Quattro Trees' (previously known as MATA tree + MPL), and 'Pollinex Quattro Grass' (previously known as MATA grass + MPL). Ragweed MATAMPL contains an extract of ragweed pollens. This extract is chemically modified with glutaraldehyde to produce the active ingredient, an allergoid. Such modification reduces the reactivity of the extract with IgE antibody. However, a simultaneous reduction in other important immunological properties, such as IgG and T cell reactivity is not seen. The modified extract is adsorbed to L-tyrosine as a depot formulation. MPL®, a purified, detoxified glycolipid derived from the cell walls of Salmonella minnesota, is also included in the current product formulation. This excipient/adjuvant is included to increase the immunogenic effect of the product and to enhance the switch from an allergen-specific TH2 to TH1-like T cell profile. The current formulation is designed to provide a product that will be efficacious with only 4 injections, in contrast to the longer schedules currently in use with unmodified extracts. The product will also be safer to use than a formulation containing a similar mass of unmodified allergen extract as regards its ability to cause severe local allergic reactions or anaphylaxis, because of its reduced reactivity with IgE antibody. The modification is greater than 75%, so that only a small amount of unmodified allergen is remaining in the product. The purpose of this study is to compare the efficacy of Ragweed MATAMPL versus placebo in ragweed-allergic subjects following 4 subcutaneous injections of study medication administered before the start of the 2007 ragweed pollen season. [/INST] Ragweed MATAMPL has been developed by Allergy Therapeutics to provide pre-seasonal specific immunotherapy for patients with proven type I hypersensitivity to cross reacting ragweed pollens causing rhinitis and/or conjunctivitis with or without mild to moderate asthma bronchiale. The purpose of this study is to compare the efficacy of Ragweed MATAMPL versus placebo in ragweed-allergic subjects following 4 subcutaneous injections of study medication administered before the start of the 2007 ragweed pollen season </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> PRIMARY OBJECTIVES: I. Assess the overall response rate (ORR) of subjects with relapsed diffuse large B-cell lymphoma (DLBCL) and peripheral T-cell lymphoma (PTCL) who are relapsed or refractory to front-line treatment and ineligible for stem cell transplantation or have recurrent disease after stem cell transplantation to oral ruxolitinib (ruxolitinib phosphate). SECONDARY OBJECTIVES: I. Evaluate safety of oral ruxolitinib in subjects with DLBCL and PTCL. II. Determine progression-free survival (PFS), duration of response, and overall response (OS) in subjects with DLBCL and PTCL. TERTIARY OBJECTIVES: I. Explore the relationship between responses to oral ruxolitinib and alterations in gene expression profiling (GEP) signatures as well as biomarker immunophenotypic changes related to JAK2/STAT3, NF-kB, PI3K/AKT, and mTOR pathways. II. Evaluate potential effect of oral ruxolitinib exposure on JAK2/STAT3 pathway inhibition in serial tumor samples. OUTLINE: Patients receive ruxolitinib phosphate orally (PO) twice daily (BID) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months thereafter. [/INST] This phase II trial studies how well ruxolitinib phosphate works in treating patients with diffuse large B-cell or peripheral T-cell non-Hodgkin lymphoma that has returned (relapsed) or that does not respond to treatment (refractory) after donor stem cell transplant. Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This is a multicenter, randomized, double-blind, vehicle-controlled study to evaluate the safety and efficacy of topically applied sofpironium bromide, 15% gel in subjects with axillary hyperhidrosis. Safety will be assessed through collection of vital signs, adverse events, local skin responses, hematology, serum chemistry laboratory testing and urinalysis. A maximum of 350 subjects will be randomized to receive either sofpironium bromide gel, 15% or vehicle. Adverse events, vital signs, and local tolerability assessments will be collected at visits across the study. Urine pregnancy tests will be taken throughout the course of the study for women of child bearing potential. Blood and urine samples will be collected and analyzed for routine hematology, chemistry, and urinalysis parameters at specified visits. Patient-reported outcome assessments will be recorded during the study at predefined time points. The study will be comprised of a total of 13 scheduled visits to take place over approximately 11 to 15 weeks. [/INST] Hyperhidrosis is a disorder of abnormal excessive sweating. Primary hyperhidrosis (armpits, hands, and feet) affects approximately 4.8% of the US population and is believed to be caused by an overactive cholinergic response of the sweat glands. Current therapies have limited effectiveness, significant side effects, and can be invasive and costly. Sofpironium bromide (BBI-4000) is a novel soft-drug in development for the topical treatment of hyperhidrosis. This Phase 3 study will assess the safety and efficacy of sofpironium bromide, 15% gel versus vehicle (2 treatment arms), applied for the treatment of axillary hyperhidrosis. </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 - w/Donepezil and Memantine[/INST] This is a phase 2a, proof-of-concept, 26-week, double-blind, multicenter, randomized, parallel group, placebo-controlled study to compare the efficacy and safety of treatment with SUVN-502 to placebo treatment in subjects with moderate Alzheimer's disease receiving stable doses of donepezil HCl and memantine HCl. </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/Bortezomib + Dexamethasone[/INST] The purpose of the study is to determine whether the addition of Elotuzumab to Bortezomib/ Dexamethasone will prolong the time before myeloma worsens [progression free survival (PFS)]. </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 - CLN-0046[/INST] To evaluate the safety, tolerability and efficacy of OTX-TKI for intravitreal use, in subjects who have neovascular age-related macular degeneration (AMD). </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive pioglitazone (rescue medication) added onto their blinded study medication [/INST] The purpose of this trial is to understand if adding saxagliptin to metformin therapy is safe and works better than taking either saxagliptin or metformin alone </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 - US Study[/INST] This research study is being conducted to find out whether Trappsol® Cyclo™, an experimental treatment for people with Niemann Pick disease Type C (NPC-1) is safe at 2 different dose levels and what effects it has on people who have this condition. NPC-1 is caused by a defect in the protein which is important for the transport of fatty substances like cholesterol out of cells. Without this protein, fats build up in the cells ultimately leading to organ damage. The way in which this experimental treatment works is not fully understood but laboratory experiments have shown that it can potentially remove cholesterol build up from the cells in people who have NPC-1. Approximately 12 patients will be asked to take part in this research study for up to 20 weeks (w) in total (including screening. treatment and follow-up). Recruitment is expected to take 6- 9 months.Patients who take part will receive treatment by an intravenous infusion every two weeks. The study will look at what the body does to the drug as well as what the drug does to the body by taking and examining blood and urine samples. A sample(s) of cerebrospinal fluid (CSF) will be taken by lumbar puncture during the first treatment dose and may be collected during subsequent doses. Liver and skin biopsy specimens will be taken to assess filipin staining. Cholesterol metabolism will be investigated in liver samples and splenic and hepatic elasticity will be assessed by ultrasound. Patients will also have their hearing tested, be asked questions by their doctor as well completing questionnaires to help assess any changes in their condition during treatment.This study is being sponsored and funded by CTD holdings Inc. It is planned to be run in the USA,. </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 - MAD[/INST] This multiple ascending dose study is to determine safety, tolerability, pharmacokinetics and immunogenicity of PRX003 in approximately 56 patients with 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 I - C-13-007[/INST] The purpose of this first-in-human study is to assess the local ocular and systemic safety and tolerability of LHA510 eye drops when administered at various concentrations and dosing frequencies. </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 - ESCAPE-1[/INST] The purpose of this study is to determine the efficacy of clevidipine injection versus placebo in treating preoperative hypertension. </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 multi-part, phase II study evaluating the combination of NIR178 and PDR001 in patients with advanced solid tumors and diffuse large B cell lymphoma (DLBCL). The study has three parts: - Part 1: Multi-arm Bayesian adaptive signal finding design in solid tumors and diffuse large B cell lymphoma (DLBCL) with continuous dosing of NIR178 in combination with PDR001. - Part 2: Exploration of continuous and intermittent NIR178 schedules in combination with PDR001 in patients with advanced non-small cell lung cancer (NSCLC). - Part 3: Further evaluation of optimal intermittent or continuous schedule of NIR178 in combination with PDR001 (if selected based on results of Part 2). As of protocol amendment 6, Part 3 explored the safety and pharmacokinetics of the film-coated tablet (FCT) formulation of NIR178 continuous dosing in combination with PDR001 in TNBC patients. In addition, a separate safety run-in part was conducted in Japan in order to adequately characterize the safety and pharmacokinetic profiles of NIR178 as a single-agent and in combination with PDR001. Patients enrolled in this study received NIR178 either twice daily (BID) continuously or based on the assigned intermittent schedule within 60 minutes prior to PDR001 infusion. PDR001 was administered via IV infusion over 30 minutes once every 4 weeks. Each treatment cycle was 28 days. Patients enrolled in the Japanese safety run-in part received NIR178 as single agent for the first cycle (28 days). If the patients completed cycle 1 without experiencing dose limiting toxicities (DLTs), they initiated combination therapy with PDR001 starting Cycle 2 onwards, and continued at the same dose of NIR178. An additional cohort in the Japanese safety run-in part of the study received NIR178 in combination with PDR001 starting with Cycle 1. If the patients complete Cycle 1 without experiencing DLTs, they continued to receive combination treatment. Patients received treatment with the combination until disease progression (assessed by investigator per immune-related response criteria (iRECIST) or Cheson 2014), unacceptable toxicity, death or discontinuation from study treatment for any other reason (e.g., withdrawal of consent, start of a new anti-neoplastic therapy or at the discretion of the investigator), otherwise known as End of Treatment. [/INST] The purpose of this phase 2 study is to evaluate the efficacy and safety of NIR178 in combination with PDR001 in multiple solid tumors and diffuse large B-cell lymphoma (DLBCL) and further explore schedule variations of NIR178 to optimize immune activation through inhibition of A2aR. </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This Phase IIB study was designed to evaluate the efficacy of hydroxychloroquine (HCQ) and azithromycin (Azithro) to prevent hospitalization or death in symptomatic adult outpatients with COVID-19 caused by SARS-CoV-2 infection. Participants were randomized 1:1 to receive active or placebo study treatment. The target sample size was 2000 participants, with approximately 1000 in each arm. Stratification was by "high" versus "low" risk of progression to severe COVID-19, where "high risk" was defined as a person age ≥60 years or having at least one of several specified comorbidities. Participants were prescribed study treatment for 7 days and were to be followed for an additional 24 weeks. Assessments on a subset of participants were planned to include blood collection, self-collected nasal swabs, and nasopharyngeal swabs. On June 23, 2020, sites were informed that the study was closing to follow-up due to slow enrollment and lack of community enthusiasm. Follow-up through week 24 was not completed for any participant. Participants were asked to complete the Day 20 visit and then were discontinued from the study. Due to the early termination, enrollment into the specimen collection subset did not occur, and results associated with those specimens are not available. Due to the small number of participants enrolled, some statistical tests were not able to be performed and only descriptive results are provided. [/INST] The purpose of this study was to evaluate the efficacy of hydroxychloroquine (HCQ) and azithromycin (Azithro) to prevent hospitalization or death in symptomatic adult outpatients with COVID-19 caused by SARS-CoV-2 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 - ECOG 5103 (HER2-)[/INST] This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with cancer that has spread to the lymph nodes (lymph node-positive) or cancer that has not spread to the lymph nodes but is at high risk for returning (high-risk, lymph node-negative breast cancer). Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, 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. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery and help prevent the tumor from returning. It is not yet known whether doxorubicin hydrochloride, cyclophosphamide, and paclitaxel are more effective with or without bevacizumab. </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 - PK/PD (Healthy Volunteers)[/INST] This study is a three part study to assess the safety and efficacy of LEZ763 on normal healthy volunteers and patients with Type 2 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 IIb/III - ZEPHYR[/INST] This Phase 2b/3 double-blind, placebo-controlled study will evaluate the safety, tolerability, and effects of livoletide on food-related behaviors in patients with Prader-Willi Syndrome (PWS). </s>

<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>> This was a phase 1/2, single center, randomized, double-blind, placebo-controlled study to assess the safety and tolerability of RMJH-111b in adult subjects with essential hypertension. Assessments of pharmacokinetics and efficacy were secondary objectives. RMJ Holdings LLC (doing business as RMJH Rx) is developing RMJH-111b (magnesium citrate, tribasic anhydrous) soft gelatin capsules for the treatment of essential hypertension. The rationale for developing RMJH-111b for essential hypertension is based on reported calcium channel blocker and vasodilator effects of magnesium cation (Mg++). Given this hypothesized mechanism of action, RMJH-111b may not be effective for subjects with other causes or forms of hypertension, and thus the diagnosis of essential hypertension was a key inclusion criterion for this trial. In order to avoid confounding the results of the trial, subjects who were already taking anti-hypertensive medications to manage their hypertension were taken off of those medications and underwent a 7-day washout period. Subjects that met the specified blood pressure criteria after the washout [systolic blood pressure (SBP) ≥ 150 and ≤ 200 mmHg and diastolic blood pressure (DBP) ≥ 95 and ≤ 115 mmHg] received placebo orally twice a day (bid) for a 3-day run-in period (Days 1-3). Subjects that were recently diagnosed or previously diagnosed and off treatment for > 1 week before starting the study and who met the blood pressure criteria proceeded directly to the 3-day run-in period (i.e., without the 7-day washout period). During the 3-day run-in period, the subjects remained in the clinical research unit (CRU) on a low salt (2.5 g/24 hours) diet. Subjects that remained eligible after the run-in period were randomized to receive either 440 mg of RMJH-111b or placebo orally bid (i.e., total daily dose of 880 and 0 mg elemental magnesium, respectively) for a 7-day treatment period (Days 4-10). A total of 21 subjects randomized 15:6 to RMJH-111b or placebo was planned. Subjects were randomized on either June 10th or 23rd of 2016. Based on the screen failure rate of the 1st cohort, the number of subjects needed for the 2nd cohort was projected. The actual number of subjects eligible for randomization at the end of the run-in period in the 2nd cohort exceeded the projection by 1 and all eligible subjects were randomized. Thus, the actual number of subjects randomized was 22, with 16 subjects in the RMJH-111b group and 6 subjects in the placebo group (i.e., 16:6 rather than 15:6). Subjects remained in the CRU on a low salt (2.5 g/24 hours) diet for the entire 7-day treatment period and through the 24-hour post treatment assessments (Day 11). Subjects returned to the clinic 8 days (±3 days) after the last dose of Study Drug (active or placebo) for their Final Study Visit. Protocol-specified reasons for discontinuing a subject from the study included, but were not limited to: 1) subject's blood pressure was too elevated for them to safely continue in the study (subjects who experienced SBP >200 mmHg or DBP >115 mmHg had to have these measurements repeated approximately 1 hour later, and if the SBP or DBP remained elevated, the subject was to be removed from the study and treated accordingly), 2) subject experienced a sharp drop in blood pressure (SBP < 110 mmHg or DBP < 60 mmHg); 3) subject's patellar reflex (knee jerk) disappeared, and 4) subject's total serum magnesium levels increased to ≥ 5 mg/dL (twice the upper limit of normal). As a conservative measure for this first trial of RMJH-111b, the criterion regarding drop in blood pressure did not require any associated clinical symptoms. For the pivotal trial, RMJH Rx will incorporate orthostatic hypotension monitoring and refine the discontinuation criterion regarding drop in blood pressure to allow for continued Study Drug treatment in the absence of clinical symptoms, so as to avoid unnecessarily removing a subject that is experiencing therapeutic benefit. All measurements used for the safety assessments in this study are widely used, and generally recognized as reliable, accurate, and relevant. Further, they included standard parameters used in the evaluation of drugs with the potential for anti-hypertensive and magnesium toxicity effects. Because blood pressure varies at daytime compared to nighttime, mean daytime (8 AM to 4 PM), nighttime (10 PM to 6 AM), and 24-hour ambulatory blood pressure monitor (ABPM) parameters were used to assess the efficacy effects of RMJH-111b on blood pressure in this trial. While 24-hour ambulatory blood pressure monitoring is considered as a more precise method for the evaluation of drug effects on blood pressure than clinic visit (seated) blood pressures, this trial also included efficacy evaluations of seated SBP and DBP parameters for informational purposes and in particular to facilitate the design of the larger pivotal trial where ABPM monitoring will not be practical. The pharmacokinetic (PK) evaluation of magnesium is complicated by pre-existing endogenous levels of magnesium, other ingested sources of magnesium (daily diet and supplements; supplements with total daily dose of magnesium ≤ 150 mg were allowed in this study), and the tight regulation of magnesium in the body (magnesium homeostasis) with relatively high levels of magnesium in bones and soft tissues compared to approximately 1% in the blood. Thus, the total serum magnesium exposure was anticipated to be minimally effected with RMJH-111b intake, but evidence of urinary magnesium excretion coupled with maintained total serum magnesium exposure was expected to provide an indication of intake rather than magnesium wasting. [/INST] The purpose of this study was to evaluate the safety of RMJH-111b, including how well it is tolerated, and the effect of RMJH-111b on blood pressure in subjects with hypertension. The study also measured the amount of magnesium in the blood and urine before and after RMJH-111b administration to evaluate what the body does to RMJH-111b (pharmacokinetics). </s>