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<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
AN OPEN-LABEL, NON-INVESTIGATIONAL PRODUCT, MULTI-CENTER, LEAD-IN STUDY TO EVALUATE
PROSPECTIVE EFFICACY AND SELECTED SAFETY DATA OF CURRENT FACTOR IX (FIX) OR FACTOR VIII
(FVIII) PROPHYLAXIS REPLACEMENT THERAPY IN THE USUAL CARE SETTING OF MODERATELY SEVERE TO
SEVERE ADULT HEMOPHILIA B SUBJECTS (FIX:C≤2%) WHO ARE NEGATIVE FOR NEUTRALIZING ANTIBODIES TO
ADENO-ASSOCIATED VIRUS VECTOR-SPARK100 (BENEGENE-1) AND MODERATELY SEVERE TO SEVERE
HEMOPHILIA A ADULT SUBJECTS (FVIII:C≤1%) WHO ARE NEGATIVE FOR NEUTRALIZING ANTIBODIES TO
ADENO-ASSOCIATED VIRUS VECTOR 6 (AAV6), PRIOR TO THE RESPECTIVE THERAPEUTIC PHASE 3 GENE
THERAPY STUDIES
[/INST]
To establish baseline prospective efficacy data of current FIX prophylaxis replacement
therapy in the usual care setting of hemophilia B subjects, who are negative for nAb to
AAV-Spark100, prior to the Phase 3 gene therapy study.
To establish baseline prospective efficacy data of current FVIII prophylaxis replacement
therapy in the usual care setting of hemophilia A subjects, who are negative for nAb to AAV6,
prior to the Phase 3 gene therapy study.
The enrollment for hemophilia A participants is completed. At this time participants are only
being enrolled for hemophilia B cohort.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This study is a double-blind randomized controlled trial designed to establish the
non-inferiority of Sci-B-Vac® compared to Engerix-B® in adults ≥ 18 years old and the
superiority of Sci-B-Vac® compared to Engerix-B® in adults ≥ 45 years old. Study subjects are
randomized 1:1 to receive either a total of 3 injections of Sci-B-Vac® or 3 injections of
Engerix-B® intra-muscularly (IM) on Days 0, 28, and 168.
[/INST]
This study is a double-blind randomized controlled trial designed to establish the
non-inferiority of Sci-B-Vac® compared to Engerix-B® in adults ≥ 18 years old and the
superiority of Sci-B-Vac® compared to Engerix-B® in ≥ 45 years old.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II/III - REACH CDM X[/INST]
This is an open-label phase 2/3 study for individuals with Congenital Myotonic Dystrophy
(Congenital DM1) who participated in the preceding AMO-02-MD-2-003 study or individuals with
either Congenital or Childhood Onset DM1 who are treatment naïve.
</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 - RESPOND[/INST]
To provide treating physicians with experience with ILUVIEN as well as monitoring its safety
(and effectiveness) in a real-life chronic diabetic macular edema (DME) patients judged
insufficiently responsive to available therapies.
</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 - SOLUTION (Anthera)[/INST]
Liprotamase powder is a non-porcine, soluble and stable mixture of three digestive enzymes
including lipase, protease, and amylase. The purpose of the present study is to provide
additional efficacy and safety data compared to approved, porcine-derived, enterically-coated
and encapsulated pancreatic enzyme replacement therapy. The primary efficacy endpoint of the
study will be comparative efficacy measured as the change in the coefficient of fat
absorption (CFA) in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).
Liprotamase is stable in stomach and digestive fluids allowing administration in a variety of
convenient formulations and with a number of foods without enteric coating.
</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 - ABATE (w/Atezolizumab)[/INST]
This is an open-label phase II study assessing the activity of cabozantinib combined with
atezolizumab in patients with resectable muscle-invasive urothelial carcinoma who are
ineligible for cisplatin-based therapy or decline cisplatin-based therapy. Each cycle equals
21 days. The dose of atezolizumab is 1200 mg IV flat dose every 3 weeks (Day 1) plus
cabozantinib 40 mg orally daily (Day 1 through Day 21). Patients will receive three cycles of
treatment prior to cystectomy unless they discontinue treatment for unacceptable toxicity or
progressive disease by RECIST v1.1 or withdraw consent.
</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 - STEADY (Study 003)[/INST]
Evaluation of efficacy and safety of testosterone enanthate administered subcutaneously using
an auto-injector
</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 - IV and SC (Healthy Volunteers)[/INST]
This is a Phase I, Randomized, Placebo-Controlled, Double-Blind Study to Assess the
Pharmacokinetics and Safety of anifrolumab following Single-Dose administration to healthy
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 I - NI-0101-01[/INST]
The purpose of this study is to determine the safety, tolerability and distribution and
elimination of a novel therapeutic drug when administered to Healthy Volunteers. In addition
its effects on some inflammatory parameters will be measured in presence or absence of
lipopolysaccharide stimulation.
</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 - w/Peg/RBV (C212)[/INST]
The purpose of this study is to evaluate the safety and tolerability of TMC435 along with
pegylated interferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) triple therapy in hepatitis C
virus genotype-1 infected subjects, co-infected with human immunodeficiency virus-type 1, and
to evaluate the number of patients with sustained virologic response (SVR) at 12 weeks after
the planned end of treatment.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - GO28885[/INST]
This is an open-label, multicenter, dose-escalation study to assess the safety, tolerability,
and pharmacokinetics of GDC-0994 in patients with locally advanced or metastatic solid
tumors. Patients will be enrolled in one of two stages: a dose-escalation stage (Stage I) or
the subsequent expansion stage (Stage II). Stage I will evaluate the safety, tolerability,
and pharmacokinetics of increasing doses of GDC-0994 administered daily. Stage II will gather
additional data on safety, tolerability, and pharmacokinetics of the recommended dose of
GDC-0994 determined in Stage I.
</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 - 049 (LHRH+, Triple Negative)[/INST]
This is a therapeutic exploratory Phase 2 study evaluating AEZS-108 compared to standard
single agent cytotoxic chemotherapy (SSCC) as measured by the median time of progression-free
survival (PFS) in patients with chemotherapy refractory triple negative (ER/PR/HER2-negative)
LHRH-R positive metastatic 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 - APOLLOE4[/INST]
This study is being conducted to evaluate the safety and efficacy of ALZ-801 in Early
Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is a double-blind,
randomized trial with one dose of ALZ-801 compared to placebo.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
131I-Metaiodobenzylguanidine (131I-MIBG) is one of the most effective therapies utilized for
neuroblastoma patients with refractory or relapsed disease. Data from pre-clinical and adult
studies suggest that radiation can enhance the efficacy of immunotherapy and targeted
therapies such as dinutuximab. This first pediatric phase 1 trial of 131I-MIBG in combination
with dinutuximab and vorinostat aims to determine the recommended phase 2 pediatric dose of
these three therapies in combination.
[/INST]
131I-Metaiodobenzylguanidine (131I-MIBG) is one of the most effective therapies utilized for
neuroblastoma patients with refractory or relapsed disease. In this pediatric phase 1 trial,
131I-MIBG will be given in combination with dinutuximab, a chimeric 14.18 monoclonal
antibody. This study will utilize a traditional Phase I rolling 6 dose escalation design to
determine a recommended phase 2 pediatric dose. An expansion cohort of an additional 6
patients will then be enrolled. If tolerable, vorinostat will then be added to the third dose
level. A 6 patient expansion cohort may then be enrolled.
</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 - TRAILBLAZER-ALZ 3[/INST]
The main purpose of this study is to evaluate the safety and efficacy of donanemab in
participants with preclinical Alzheimer's Disease (AD).
</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 - Proof of Concept[/INST]
The primary purpose of this study is to examine safety outcomes in active plaque psoriasis
patients after systemic administration of dalazatide. Clinical outcome measures will also be
assessed.
</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 - Lung PK[/INST]
The primary purpose of this study is to determine the steady-state plasma pharmacokinetics
(PK) and properties of TR-700 into the pulmonary epithelial lining fluid (ELF) and alveolar
macrophages (AM) of healthy volunteers.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Colorectal cancer (CRC) ranks as the third most common cancer worldwide. Metastasis is the
main reason of death in CRC patients. The current drugs used to treat colorectal cancer
provide important treatment options for patients, their limitations including drug
resistance, poor efficacy and severe side effects. Development of new therapeutic strategies
for KRAS mutant as well as BRAF mutant tumors are therefore highly needed in order to offer a
new category of drug (immunotherapy). This study targets the population of mCRC patients that
have progressed after two lines of chemotherapy and are not eligible for targeted therapies.
The study will assess six different dosing schedules. A standard 3 plus 3 study design will
be used. The starting frequency for each dosing schedule will be escalated in subsequent
groups of patients. The study will evaluate safety of increased frequency of AlloStim® dosing
and anti-tumor effect of the new proposed dose and frequency schedule.
[/INST]
This is a single center, open label dose frequency escalation study of CryoVax®. personalized
anti-tumor vaccine protocol combining the cryoablation of a selected metastatic lesion with
intra-lesional immunotherapy with AlloStim®. The in-situ (in the body) cancer vaccine step
combines killing a single metastatic tumor lesion by use of cryoablation in order to cause
the release of tumor-specific markers to the immune system and then injecting bioengineered
allogeneic immune cells (AlloStim®) into the lesion as an adjuvant in order to modulate the
immune response and educate the immune system to kill other tumor cells where ever they
reside in the body.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - Safety Study[/INST]
The primary purpose is to evaluate the safety and tolerability of ASP6981 in participants
with schizophrenia.
Also primary purpose is to evaluate the pharmacodynamics of ASP6981 in participants with
schizophrenia as measured by cognitive function and neurophysiological biomarkers.
The secondary purpose of this study is to evaluate the pharmacokinetics of ASP6981 in
participants with schizophrenia.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - TALON (Superiority vs. Aflibercept)[/INST]
The was a 64-week randomized, double-masked, multi-center, active-controlled, two-arm study
in patients with neovascular age related macular degeneration (nAMD) who have not previously
received anti- vascular endothelial growth factor (VEGF) treatment.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Ocular GVHD (oGVHD) is a common complication that occurs in 40-60% of patients who have
undergone allogeneic bone marrow transplants. Driven by inflammation, oGVHD can result in
damage to the ocular surface and tear-producing glands, which over time significantly
diminishes quality of life and restricts daily activities due to visual impairment.
Early studies in animals and humans indicate that Brimonidine nano-emulsion, also known as
OCU300, may relieve the signs and symptoms of oGVHD. These symptoms include blurry vision,
foreign body sensation, burning sensation, severe light sensitivity, chronic conjunctivitis
(pink or red eye), dry eyes and eye pain.
This study will be a randomized, placebo-controlled, double-masked, multicenter phase 3 study
in the United States conducted at approximately 15 centers. Upon meeting the eligibility
criteria, enrolled subjects with a diagnosis of definite oGVHD will be randomly assigned in a
2:1 (test: control) fashion to receive either Brimonidine Nanoemulsion Eye Drops 0.18%
investigational product (test) or ophthalmic buffered saline (placebo).
[/INST]
This study evaluates the use of Brimonidine tartrate nanoemulsion eye drop solution in the
treatment of ocular Graft Verses Host Disease (oGVHD). Two thirds of participants will
receive Brimonidine and one third will receive ophthalmic buffered saline (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 II/III - 006 - Dose Ranging[/INST]
A Randomized, Double-Blind, Dose-Ranging, Dose Comparison-Controlled Trial to Determine the
Safety and Efficacy of BMS-298585 in Subjects 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 I - M13-334[/INST]
This study is designed to evaluate the safety, tolerability and pharmacokinetics of multiple
doses of ABT-957 in subjects with mild to moderate Alzheimer's disease.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I/II - EGFR+ Solid Tumors[/INST]
RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory
into patient autologous T cells may make the body build immune response to kill cancer cells.
PURPOSE: This clinical trial is to study genetically engineered lymphocyte therapy in
treating patients with EGFR positive advanced/unresectable operation solid tumors, such as
lung cancer, colorectal cancer，ovary cancer，cholangiocarcinoma，pancreatic cancer，renal
carcinoma and other relapsed/metastatic tumors.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - Dental Postsurgical Pain[/INST]
The purpose of the study is to determine whether Naproxen Test Formulation Capsules are safe
and effective for the treatment of dental pain.
</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 - Long-Term (NHGRI)[/INST]
This 3-year study will examine the safety and effectiveness of long-term use of nitisinone
(Orfadin) for treating joint problems in patients with alkaptonuria, an inherited disease in
which a compound called homogentisic acid accumulates. The excess homogentisic acid causes
arthritis and limited joint movement. It can also cause heart valve damage and kidney stones.
Patients between 30 and 80 years of age with alkaptonuria may be eligible for this study.
Patients must have hip involvement, but at least one remaining hip joint. Candidates are
recruited from among patients enrolled in protocol 00-HG-0141, "Clinical, Biochemical, and
Molecular Investigations into Alkaptonuria." Participants may enter both protocols
simultaneously.
Participants are randomly assigned to one of two treatment groups: one group takes their
regular medicines plus a 2-mg nitisinone capsule daily; the other group takes only their
regular medicines. Patients taking nitisinone have blood tests to measure liver function 2
weeks and 6 weeks after starting treatment. Before starting therapy, all patients are
admitted to the NIH Clinical Center for 4-5 days to undergo the following procedures:
- Medical history and physical examination
- 24-hour urine collection to test for sugar, protein, and other molecules
- Blood tests for liver and thyroid function, blood counts, and blood chemistries
- Blood and urine tests to measure tyrosine and other amino acids and homogentisic acid
- Bone x-rays
- Spiral CT (computed tomography) of the abdomen to detect kidney stones
- Eye examination and evaluations by specialists in rehabilitation medicine and pain, plus
other consults in skin, brain, lung, heart, and kidney, as needed
All patients, whether or not they receive nitisinone, return to the Clinical Center for a 2-3
day follow-up admission every 4 months for a history and physical examination, blood tests,
and two 24-hour urine collections. Every 12 months (12, 24 and 36 months after starting the
study), patients also have repeat bone x-rays, spiral CT, kidney ultrasound, echocardiogram,
and electrocardiogram. An Magnetic Resonance Imaging (MRI) of the brain is done at the end of
the study.
Sixteen months after the end of the study enrollment period, the treated and non-treated
groups are evaluated. If nitisinone has delayed the progression of joint disease in the
treated group, the study continues and all patients receive the drug for the remainder of the
study. If not, the study continues for another 20 months, at which time the study ends and
the evaluation process is repeated.
Patients who develop symptoms such as corneal crystals, pain, or severe liver or nervous
system toxicity may be taken off the study.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Phase 1 Dose-Finding
Is the open-label dose-finding portion of the study that will evaluate safety, tolerability,
and immunogenicity of BNT162b2 administered on a 2-dose (separated by approximately 21 days)
schedule in up to 3 age groups (participants ≥5 to <12 years, ≥2 to <5 years, and ≥6 months
to <2 years of age).
Dose finding is being initiated in this study in participants ≥5 to <12 years of age based on
the acceptable blinded safety assessment of the 30-µg dose in 12- to 15-year-olds in the
C4591001 study.
The purpose of Phase 1 is to identify preferred dose level(s) of BNT162b2 from up to 3
different dose levels in each age group.
Dependent upon safety and/or immunogenicity data generated during the course of this study,
it is possible that dose levels may not be started, may be terminated early, and/or may be
added with dose levels below the lowest stated dose.
Update as part of protocol amendment 6: All participants will receive a third dose of
BNT162b2. For participants ≥6 months to <5 years, the third dose will occur at least 8 weeks
after the second dose. In participants ≥5 to <12 years, the third dose will occur at least 6
months after the second dose. The interval between the second and third doses will be based
on the participant's age at the time of enrollment. The dose level of the third dose of
BNT162b2 will be based on age at the time of vaccination: participants <5 years of age at the
time of the third dose will receive the 3-µg dose level, participants ≥5 to <12 years of age
at the time of the third dose will receive the 10-µg dose level, and participants ≥12 years
of age at the time of the third dose will receive the 30-µg dose level.
Participants will have blood drawn prior to both Dose 1 and Dose 2 and 7 days after Dose 2 to
assess immunogenicity to determine the selected BNT162b2 dose level for Phase 2/3.
Participants will also have blood drawn prior to Dose 3 and 1, 6, and 12 months after Dose 3.
Phase 2/3 Selected-Dose
Is the portion of the study that will evaluate the safety, tolerability, and immunogenicity
in each age group at the selected dose level from the Phase 1 dose-finding portion of the
study. Efficacy will be evaluated within or across age groups in which immunobridging is
successful, depending on accrual of a sufficient number of cases in those age groups.
Participants will have blood drawn at baseline prior to Dose 1 and 6 months after Dose 2.
Immunobridging to participants 16 to 25 years of age in the C4591001 study will be based on
immunogenicity data collected at (1) baseline and 1 month after Dose 2 and (2) baseline and 1
month after Dose 3. The persistence of the immune response will be based on immunogenicity
data collected in participants at (1) baseline and 1 and 6 months after Dose 2 and (2)
baseline and 1, 6, 12, and 18 months after Dose 3. In addition, efficacy against confirmed
COVID-19 and against asymptomatic infection will also be assessed in participants ≥5 to <12
years of age.
At designated US sites, an additional optional whole blood sample of approximately 10 mL will
be obtained prior to Dose 1 and at 7 days and 6 months after Dose 2 from up to approximately
60 participants ≥10 years of age. Additional samples will be obtained prior to Dose 3 and 1
month after Dose 3 (original BNT162b2 group only). These samples will be used on an
exploratory basis to investigate the postvaccination cell-mediated immune response at these
time points.
At the 6-month follow-up visit, all participants will be unblinded. Participants who
originally received placebo will be offered the opportunity to receive BNT162b2 as part of
the study. Participants who originally received placebo and become eligible for receipt of
BNT162b2 or another COVID-19 vaccine according to local or national recommendations prior to
the 6 month follow-up visit (Visit 5 or 405) (detailed separately and available in the
electronic study reference portal) will have the opportunity to receive BNT162b2 (10 µg or 3
µg) based on age at the time of vaccination.
Update as part of protocol amendment 6: All participants will receive a third dose of
BNT162b2. For participants ≥6 months to <5 years, the third dose will occur at least 8 weeks
after the second dose. In participants ≥5 to <12 years, the third dose will occur at least 6
months after the second dose. The interval between the second and third doses will be based
on the participant's age at the time of enrollment. The dose level of the second and third
doses of BNT162b2 will be based on age at the time of vaccination: participants <5 years of
age at the time of the second/third dose will receive the 3-µg dose level, participants ≥5 to
<12 years of age at the time of the second/third dose will receive the 10-µg dose level, and
participants ≥12 years of age at the time of the second/third dose will receive the 30-µg
dose level.
Phase 2/3 Obtaining Serum Samples for Potential Troponin I Testing
If testing of troponin I levels in individuals who did not receive BNT162b2 indicates that
troponin I level could be a reliable indicator of potential subclinical myocarditis,
obtaining serum samples for potential troponin I testing during the period of increased risk
of clinical myocarditis may help characterize the absence/presence and frequency of
subclinical myocarditis. To assess, an additional group of participants will be included: ≥5
to <12 years: randomized 2:1 to receive BNT162b2 10 µg or placebo, and ≥12 to <16 years of
age: open-label receipt of BNT162b2 30 µg.
Update as part of protocol amendment 7: All participants will receive a third dose of
BNT162b2. For all participants (≥5 to <12 and ≥12 to <16 years of age), the third dose will
occur at least 5 months after Dose 2.
The dose level of the second and third doses of BNT162b2 will be based on age at the time of
vaccination: participants ≥5 to <12 years of age at the time of the second/third dose will
receive the 10-µg dose level, and participants ≥12 years of age at the time of the
second/third dose will receive the 30-µg dose level.
Update as part of protocol amendment 8: The Lower-Dose Evaluation portion of the protocol has
been removed.
Participation in the study will cease 6 months after the third dose of BNT162b2.
[/INST]
This is a Phase 1/2/3 study in healthy children.
Dependent upon safety and/or immunogenicity data generated during the course of this study,
and the resulting assessment of benefit-risk, the safety, tolerability, and immunogenicity of
BNT162b2 in participants <6 months of age may subsequently be evaluated.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Eligible participants who completed the first course of up to 35 administrations of
pembrolizumab (approximately up to 2 years) for reasons other than disease progression or
intolerability, may be eligible for a second course of pembrolizumab for up to approximately
1 additional year at the investigator's discretion. Per protocol, response during this second
course will not count towards the efficacy outcome measures and adverse events during this
second course will not count towards the safety outcome measures.
Protocol Amendment 01 (08 Aug 2013) included a new study arm (Cohort D) for approximately 32
participants with advanced gastric cancer. Of these 32 participants, 16 will be from sites in
the Asia Pacific (AP) region and the other 16 will be from sites outside the AP region.
Protocol Amendment 02 (07 Apr 2014) added a new study arm (Cohort B2) for approximately 110
participants with advanced head and neck cancer who will receive a lower dose of
pembrolizumab every three weeks (Q3W). Both programmed cell death ligand 1 (PD-L1)- positive
and PD-L1-negative participants will be enrolled into this cohort.
Protocol Amendment 03 (26 May 2015) removed the secondary objective of investigating the
relationship between programmed cell death 1 (PD-1) inhibition and up-regulation of cytokines
biomarkers predicting response (e.g. Interleukin-10 [IL-10]) from the protocol.
Participants who stopped study treatment without progression (e.g. completed 2 years) may
have been eligible for up to 1 year of retreatment upon subsequently experiencing disease
progression.
With Amendment 05 (11 Dec 2017), once study participants have achieved the study objective or
the study has ended, participants will be discontinued from this study and enrolled in an
extension study (KEYNOTE-587; NCT03486873) to continue protocol-defined assessments and
treatment.
[/INST]
This study is being done to investigate the safety, tolerability and anti-tumor activity of
pembrolizumab (MK-3475) in participants with advanced triple negative breast cancer (TNBC)
(Cohort A), advanced head and neck cancer (Cohorts B and B2), advanced urothelial cancer
(Cohort C), or advanced gastric cancer (Cohort D). Additionally, for Cohort D, data is
presented for Asian Pacific (AP) participants. Only participants with programmed cell
death-ligand 1 (PD-L1) expressing tumors were enrolled in Cohorts A, B, C and D. Participants
in Cohort B2 were enrolled irrespective of PD-L1 status.
The primary study hypothesis is that pembrolizumab is safe and well-tolerated.
</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 - CompoSIT-R (vs dapagliflozin, mild renal impairment)[/INST]
The purpose of the study is to assess the effect of the addition of sitagliptin to metformin
with or without a sulfonylurea compared with the addition of dapagliflozin to metformin with
or without a sulfonylurea on hemoglobin A1c (A1C) over 24 weeks of treatment as well as the
overall safety and tolerability of sitagliptin in comparison to that of dapagliflozin after
24 weeks of treatment. The primary hypothesis is that the change from baseline in A1C in
participants treated with the addition of sitagliptin is non-inferior compared to that in
participants treated with the addition of dapagliflozin after 24 weeks of treatment.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Administration Schedule: 1 cycle of Oraxol® is 28 days and Oraxol® is administrated twice a
week, total 6 times per cycle (day 1,2,8,9,15 and 16).
[/INST]
The main objectives of this study are to determine the maximum tolerated dose (MTD) and
recommend dose (RD) of Oraxol® in Phase I and to determine the objective response rate of
Oraxol® in Phase II.
</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/Prednisone (M.D. Anderson Cancer)[/INST]
The goal of this clinical research study is to learn if lenalidomide in combination with
prednisone can help to control myelofibrosis. The safety of lenalidomide and prednisone for
the treatment of myelofibrosis will also be studied.
</s> |
<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/Metformin[/INST]
This study will compare the safety, tolerability and efficacy of the combination of KD026 and
metformin compared to placebo and metformin on improving glycemic control in patients with
type 2 diabetes mellitus.
</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 - 115951[/INST]
The purpose of this research study is to:
- 1) Test the safety and tolerability of 2 different oral doses of SRT2104 in subjects
with ulcerative colitis
- 2) Determine the amount of SRT2104 measured from a single blood sample in addition to
colon and/or rectal tissue samples (biopsies)
- 3) Determine whether SRT2104 has any anti-inflammatory effect on the colon and/or rectum
when taken orally for 8 weeks
- 4) Determine whether SRT2104 causes any detectable changes to specific biomarkers. A
biomarker is a biological marker (or substance such as a protein) that is used as an
indicator of changes in a biological state that corresponds to the risk or progression
of a disease.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - vs. Neostigmine/Glycopyrrolate [/INST]
This study will compare the incidence of residual neuromuscular blockade in participants who
undergo reversal of neuromuscular blockade with sugammadex compared to those who undergo
reversal of neuromuscular blockade with usual care (neostigmine/glycopyrrolate).
</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 - ALTA (Crizotinib-Resistant)[/INST]
The purpose of this study is to evaluate the efficacy and safety of two different dosing
regimens of brigatinib (AP26113) in participants with ALK-positive locally advanced or
metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on therapy with
crizotinib.
</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 - JAVELIN Ovarian 200[/INST]
A Phase 3 global study comparing avelumab alone to avelumab plus PLD and to PLD alone to
demonstrate that avelumab given alone or in combination with PLD is superior to PLD alone in
prolonging Overall Survival in patients with platinum resistant/platinum refractory ovarian
cancer.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - Patients Undergoing Abdominal Surgery (Israel)[/INST]
Subjects who are planned to undergo an abdominal (colon) surgery and who will meet the study
entry criteria will be randomly divided into 2 groups: for half D-PLEX will be administered
concomitantly with the standard of care (SOC). The other half will receive the Standard of
Care treatment.
Following the surgery subjects will be followed up for additional 5 visits, at least half are
in line with the routine practice of surgery Follow-Ups.
Visits will include patient safety and wound assessments.
</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 - 3003 (Mexico)[/INST]
The purpose of this study is to evaluate the efficacy and safety of oral administration of 24
ug of lubiprostone twice daily (BID) for 4 weeks in participants with chronic idiopathic
constipation (CIC) compared with 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 II - GMAIS[/INST]
The purpose of this research study is to determine whether the investigational drug GM602, is
effective and safe in the treatment of ischemic stroke (strokes caused by a blood clot
blocking the flow of blood through one, or more of the blood vessels supplying the brain)
when administered up to 18 hours after symptoms begin.
</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 - IFUM[/INST]
This study is carried out to see how Caucasian patients with lung cancer which has EGFR
mutation will respond to gefitinib (IRESSA™) as a first line treatment. Safety data will also
be collected and analysed to confirm that treatment with gefitinib is safe and well
tolerated.
</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 - CL-004 (Castration-Resistant)[/INST]
The goal of this clinical study is to determine the safety, tolerability, pharmacokinetics
and activity of once-daily (QD) oral dosing of VT-464, a lyase-selective inhibitor of CYP17,
in patients with castration-resistant prostate cancer (CRPC).
</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 - 20170122[/INST]
The primary purpose of the phase 1 part of the study is to evaluate safety and tolerability
of AMG 701 monotherapy to identify the RP2D for AMG 701 monotherapy followed by a
dose-confirmation part to gather further safety data for AMG 701 monotherapy at the RP2D in
adult subjects with relapsed/refractory multiple myeloma (RRMM). In addition, this study will
include a sequential dose exploration part to identify the RP2D of AMG 701 in combination
with pomalidomide, with and without dexamethasone (AMG 701-P+/-d). Phase 2 will consist of
the dose-expansion part to gain further efficacy and safety experience with AMG 701
monotherapy in adult subjects with RRMM.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - 2001 (Acute Myocardial Infarction)[/INST]
This study is a phase 2, multicenter, double-blind, randomized, placebo controlled,
parallel-group study to investigate the renal safety and tolerability of multiple dose
intravenous (IV) administration of CSL112 compared with placebo in subjects with moderate
renal impairment (RI) and acute myocardial infarction (AMI).
</s> |