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<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This study is to enroll 208 subjects (184 fully evaluable) with nonsense-mutation-mediated CF
who are at least 6 years of age and have an forced expiratory volume in 1 second (FEV1) >=
40% and <= 90% of predicted. Subjects will be stratified based on age, inhaled antibiotic
use, and baseline FEV1, and will be randomized in a 1:1 ratio to receive oral ataluren
administered 3 times per day (TID) at respective morning, midday, and evening doses of 10-,
10-, and 20-mg/kg or placebo. Based on the results of a previously conducted study, patients
treated with chronic inhaled aminoglycosides (including TOBI) will not be eligible for
participation. Spirometry measurement at the screening visit will establish patient
eligibility for inclusion based on lung function. FEV1 stability will be assessed during the
approximately 4-week screening period, at the conclusion of which patients will be required
to demonstrate a relative change in %-predicted FEV1 of less than 15% when compared to the
screening value. Assessments will be performed every 8 weeks, depending upon the outcome
measure.
[/INST]
This is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled,
efficacy and safety study of ataluren in patients with nonsense mutation cystic fibrosis
(nmCF) not receiving chronic inhaled aminoglycosides.
</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 - ALECARDIO (CV Outcomes)[/INST]
This double-blind, parallel, two-arm study will evaluate the potential to reduce
cardiovascular risk, the tolerability and long-term safety profile of aleglitazar compared to
placebo on top of standard care in patients with recent acute coronary syndrome (ACS) and
type 2 diabetes mellitus. Patients will be randomized to receive either aleglitazar or
placebo once daily as oral doses. The study will last until at least 950 events occur, but
time on study treatment will be for at least 2.5 years.
</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 - ALLEVIATE[/INST]
The purpose of this study is to evaluate the efficacy of eptinezumab in participants with
episodic Cluster Headache (eCH)
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This is a randomized, double-blind, sequential escalating repeat daily dose study conducted
in two parts. The first part is being conducted in healthy subjects and will evaluate safety,
tolerability, and pharmacokinetics and pharmacodynamics of escalating EVP-0962 doses (10, 50
100 and 200 mg) or matching placebo following once-daily administration for 14 days. The
second part will evaluate the safety, tolerability and pharmacokinetics and pharmacodynamics
of EVP-0962 following once-daily administration for 14 days in patients with mild cognitive
impairment or early Alzheimer's disease at the dose level selected based on the available
safety, pharmacokinetics and pharmacodynamics observations in the first part.
[/INST]
This study is being conducted to determine the safety, tolerability, pharmacokinetics, and
effects of EVP-0962 on cerebral spinal fluid Amyloid concentrations in healthy subjects and
in subjects with mild cognitive impairment or early Alzheimer's disease.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This is a Phase III, randomized, double-blind, double-dummy, active-controlled, parallel
group multi-center trial, designed to evaluate the non-inferiority of CAM2038 compared to an
existing standard of care (SL BPN/NX) in initiation and maintenance treatment with BPN. The
trial will involve 4 phases: Screening, Phase 1 (weekly visits), Phase 2 (monthly visits),
and Follow-up.
Approximately 380 subjects (190 subjects per arm) will be randomized.
[/INST]
Phase III, randomized, double-blind, double-dummy, active-controlled, parallel group
multi-center trial, designed to evaluate the non-inferiority of CAM2038 compared to an
existing standard of care (SL BPN/NX) in initiation and maintenance treatment with BPN.
</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 - 002[/INST]
The primary objective of this study is to evaluate the safety and tolerability of 3 planned
doses of ONO-9054 in the eyes of adult male and female patients with ocular hypertension
(OHT) or mild open angle-glaucoma (OAG).
The secondary objectives are to evaluate Pharmacodynamics (PD) and to characterize the
pharmacokinetic (PK) profile of ONO-9054 and its metabolite in plasma and to compare its
tolerability following morning and evening 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 2, multicenter, open-label, randomized study to evaluate the efficacy and
safety of SHAPE Gelled Solution applied topically daily or twice daily for 26 consecutive
weeks to specified skin lesions in patients with Stage IA, IB or IIA CTCL. Patients
responding to treatment will be allowed to continue on study for a maximum of 52 weeks.
[/INST]
The purpose of this study is to evaluate the efficacy, safety and tolerability of SHAPE
administered topically to skin lesions in patients with early-stage cutaneous T-cell lymphoma
(CTCL).
</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 - ENHANCE 1 (w/Pembrolizumab)[/INST]
This is an open-label, single-arm, multicenter, Phase 1b/2 study of eribulin mesylate in
combination with pembrolizumab in participants with mTNBC previously treated with 0 (stratum
1) or 1 to 2 (stratum 2) lines of systemic anticancer therapy (cytotoxic or targeted
anticancer agents) in the metastatic setting.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - Pediatric (Ages 6-18) Functional Constipation[/INST]
This study is for children with constipation.
Children who completed 3 months of treatment in the earlier study (NCT02042183):
- were invited to participate
- will receive lubiprostone for 9 more months
- will see if lubiprostone safely relieves their constipation if taken for a whole year
</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/INO-9012[/INST]
The central premise of our program is that durable control of HIV in the absence of
antiretroviral therapy ("remission") will require the generation of de novo potent and
sustained HIV-specific CD8+ cell responses that target evolutionarily conserved epitopes. Our
program is inspired by the recent success of VGX-3100 (Inovio), a DNA therapeutic vaccine for
HPV that leads to histopathologic regression of pre-malignant lesions in people and is
associated with a potent, sustained boost to HPV-specific CD8+ T cell populations. A closely
related multi-clade gag/pol/env DNA vaccine administered with an IL-12 DNA plasmid (PENNVAX,
Inovio) has been studied for HIV prevention and is known to be both safe and highly
immunogenic. In a randomized placebo-controlled study we will compare the immunogenicity and
anti-reservoir activities of gag/pol DNA versus gag/pol/env DNA (both administered with
IL-12). We will determine for the first time in established HIV disease whether presence of
env in a DNA vaccine blunts T cell responses to more conserved Gag-specific and Pol-specific
epitopes. We will also determine if Env-specific responses (which will presumably be mediated
by antibodies and antibody-dependent cellular cytotoxicity, or ADCC) have a measurable effect
on reservoir.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This is a 3-part study to examine the efficacy, safety, tolerability, PK, and PD of tofersen.
Part A is the single ascending dose (SAD) component of the study, Part B is the multiple
ascending dose (MAD) component of study and Part C is the fixed dose component of the study.
Hence, the overall phase of development of the study is 1/2/3.
The study completed on 16 Jul 2021. In total, the study enrolled 176 participants, of which
108 enrolled in Part C.
[/INST]
The primary objectives of Parts A and B of this study are to evaluate the safety,
tolerability, and pharmacokinetics (PK) of ascending doses of tofersen in adults with ALS and
a documented superoxide dismutase 1 (SOD1) mutation. The primary objective of Part C of this
study is to evaluate the clinical efficacy of tofersen administered to adults with ALS and a
confirmed SOD1 mutation.
The secondary objective of Parts A and B of this study is to evaluate the effects of tofersen
on levels of total SOD1 protein in the cerebrospinal fluid (CSF). The secondary objectives of
Part C are to evaluate the safety, tolerability, pharmacodynamic (PD), and biomarker effects
of tofersen.
</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 - Rollover Study (Continued Access)[/INST]
This study is to allow continued use of ribociclib (LEE011) as single agent or in combination
with other investigational treatments in patients benefitting from treatment in an eligible
Novartis-sponsored ribociclib (LEE011) study that has reached its primary objective(s) or has
been halted for other reasons.
</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/Lenalidomide[/INST]
This phase I/II trial studies the side effects and best dose of lenalidomide when given
together with R-(-)-gossypol acetic acid and to see how well they work in treating patients
with B-cell chronic lymphocytic leukemia (B-CLL) that has returned after a period of
improvement (relapsed). Biological therapies, such as lenalidomide, may stimulate the immune
system to attack cancer cells. R-(-)-gossypol acetic acid may stop the growth of cancer cells
by blocking some of the enzymes needed for cell growth and causing the cells to die. Giving
lenalidomide with R-(-)-gossypol acetic acid may be an effective treatment for relapsed or
refractory B-CLL. - Funding Source - FDA OOPD
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Phase 1, open-label, 2-part, single-dose pharmacokinetic and safety study of STS101 in
healthy subjects. Part 1 was designed to identify a dose level of STS101 for administration
in Part 2. Subjects in Part 1 received 3 ascending doses of STS101 in a 3-period crossover
manner. During Part 2, subjects received the dose of STS101 selected from Part 1, 1.0 mg DHE
mesylate IM injection, and 2 mg DHE mesylate nasal spray in a randomized, 3 period crossover
manner.
[/INST]
Single-center, single-dose, open-label, 2-part, 3-period crossover (in each part),
pharmacokinetic and safety 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 III - C-07-13 - Acute Otitis Externa[/INST]
The purpose of this study is to determine if an otic formulation is safe and effective for
the treatment of acute otitis externa (AOE).
</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 - ENDOMAX (Endocvascular Interventions)[/INST]
The primary objective of the study is to test whether anticoagulation with bivalirudin
results in fewer major bleeding complications compared with unfractionated heparin (UFH) in
participants undergoing peripheral endovascular interventions (PEI). The secondary objective
is to test whether there were potential benefits from bivalirudin therapy on other clinically
important events such as death, myocardial infarction (MI), stroke and/or transient ischemic
attack (TIA), amputation, unplanned repeat revascularization (URV), and minor bleeding, as
well as potential economic benefits that may result from improved clinical outcomes.
</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 - A2307 - STATURE[/INST]
The study will assess the safety and efficacy of intravenous (10mg/kg) and subcutaneous
(300mg) secukinumab in moderate to severe chronic plaque-type psoriasis who are partial
responders to secukinumab.
</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 - REN-001A [/INST]
This is a Phase 1b, single-center, dose-escalating study to evaluate the safety,
tolerability, pharmacokinetics, and pharmacodynamic effect of RBT-1 in healthy volunteers and
in subjects with Stage 3-4 CKD.
</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, placebo-controlled cross study designed to evaluate the safety and
efficacy of autologous immunoregulatory dendritic cells (iDC) in patients with type 1
diabetes. To do this, a total of 24 subjects with recent onset (<100 days from diagnosis)
type 1 diabetes will have circulating dendritic cells harvested via leukapheresis. The
harvested dendritic cells will then be incubated in vitro with antisense DNA oligonucleotides
targeting the primary transcripts of cluster of differentiation antigen 40 (CD40), cluster of
differentiation antigen 80 (CD80) and cluster of differentiation antigen 86 (CD86). These
engineered dendritic cells will then be given as autologous intradermal injections (4
injections administered at 2 week intervals) in the subject' peri-umbilical region. The
hypothesis is that the injected cells will generate immunoregulatory cells that suppress the
autoimmune process responsible for the development of type 1 diabetes via destruction of the
subject's pancreatic beta cells.
Employing a cross-over design, all subjects will undergo leukapheresis at the outset. Twelve
subjects will be randomly assigned to receive cell injections at the outset while the other
12 subjects will receive sham injections and serve as controls. At the end of 12 months, all
subjects will cross-over to the alternative treatment and continue to be followed for an
additional 12 months. (Note: The subjects assigned to receive the cell therapy for this
segment will receive injections of their autologous cells harvested and engineered at the
time of the leukapheresis performed at study entry. The engineered cells will be stored
frozen until needed for administration. This design will test whether treatment later (>1
year after diagnosis) is as effective as immediate treatment (<100 days from the diagnosis of
type 1 diabetes).
As an added safety measure, the first 6 subjects randomized will all be over the age of 18.
When the last of these 6 subjects complete 3 months of observation following the initiation
of therapy, the age for enrollment will be lowered to age 16 for the next 6 subjects unless
safety observations dictate otherwise. When all subjects in this cohort have been enrolled,
the age for enrollment will be lowered to age 14 unless advised otherwise by the independent
Data Safety Monitoring Board. When all subjects in this cohort have completed observation for
3 months, the age for enrollment will be lowered to age 12 following clearance by the Data
Safety Monitoring Board.
If this therapy is successful, the subjects' remaining beta cell mass will be preserved and
hopefully expanded once the autoimmune process is slowed or stopped. This outcome will be
assessed indirectly using plasma c-peptide concentrations following ingestion of a
standardized mixed meal at the end of 12 and 24 months of therapy. If the treatment is
successful, glucose control should improve and be detectable via measurement of hemoglobin
A1c (measure of long-term control), fasting plasma glucose concentrations and the plasma
glucose concentrations following ingestion of the standardized mixed meal. In addition, the
total daily insulin requirements should decrease. These measures of glucose control will be
assessed at baseline and then at 3, 6, 9, 12, 15, 18, 21 and 24 months.
Immune markers will also be profiled at 3 month intervals to assess potential tolerogenic
effects of the therapy. To this end, numbers of potentially tolerogenic/regulatory T-cells,
B-cells and dendritic cells in the circulating peripheral blood monocyte population will be
assessed. In addition, analysis of selected populations of T-cells, B-cells and dendritic
cells will be conducted over the entire study period in an attempt to identify molecular
signatures correlated with the clinical response.
Finally, in addition to the routine safety laboratory measurements, all reported adverse
events will be examined in detail to characterize the safety aspects of the therapy. The
review of these safety data will be guided by an independent Data Safety Monitoring Board
which will meet at least semi-annually to review the accrued data.
[/INST]
The purpose of this study is to determine whether dendritic cells collected via leukapheresis
and incubated with antisense DNA oligonucleotides and then injected back into the same
subject will serve as modulators of the immune system in a manner that disrupts the
autoimmune process responsible for the destruction of pancreatic beta cells in subjects with
new onset type 1 diabetes.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - First Line[/INST]
The objective is to evaluate the efficacy and safety of AB1010 at 7.5 mg/kg/day in the
treatment of non pre-treated, inoperable patients with locally advanced/metastatic GIST.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase IIIb - Total Knee Arthroplasty[/INST]
Phase 3b, open-label single-arm study in which all subjects receive HTX-011 as part of a
scheduled non-opioid MMA regimen.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
The drugs being tested in this study are called TAK-580, TAK-202 (plozalizumab), and
vedolizumab. These investigational drugs were given along with standard of care checkpoint
inhibitors ([nivolumab in Arms 1 and 2] or nivolumab + ipilimumab in Arm 3). This study
looked at the safety profile of the combination treatments in each arm when administered to
participants with metastatic melanoma.
The study planned to enroll approximately 156 participants. Participants were assigned to one
of the 3 treatment groups:
- TAK-580 + nivolumab
- TAK-202 (plozalizumab) + nivolumab
- vedolizumab + nivolumab + ipilimumab
This study consists of 3 parts. A dose-escalation safety lead-in phase, confirmatory safety
phase and a cohort expansion phase. This multi-center trial will be conducted in the United
States. The overall time to participate in this study is 50 weeks. Participants may make
multiple visits to the clinic and 30, 60, and 90 days after last dose of study drug for
follow-up assessments.
[/INST]
The purpose of this study is to determine the initial safety profile and initial antitumor
activity of the combination treatments (immune checkpoint inhibitors [nivolumab, ipilimumab]
with investigational drugs [TAK-580, TAK-202 (plozalizumab), vedolizumab]) in the 3 arms when
administered to participants with advanced melanoma.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I/II - Monotherapy (501)[/INST]
Establishment of safety profile of HuMax-CD38 when given as monotherapy in participants with
multiple myeloma relapsed from or refractory to at least 2 different cytoreductive therapies
and without further established treatment options.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
The study duration for an individual patient will include a screening period for inclusion of
up to 21 days. The treatment period may continue until disease progression, unacceptable
adverse reaction, or other reason for discontinuation. After study treatment discontinuation
an end of treatment (EOT) visit will be done at approximately 30 days after last study
treatment component administration to assess safety. If the last ADA sample is positive or
inconclusive, additional ADA will be sampled 3 months later. No further ADA will be sampled,
even if this 3-month sample is positive. Patients who discontinue treatment for reasons other
than progression of disease will be followed every month until progression or initiation of
subsequent therapy, for a maximum of one year, whichever comes first.
[/INST]
Primary Objectives:
Part A: To evaluate the safety and determine the recommended dose of SAR650984 in combination
with pomalidomide (P) and dexamethasone (d), in patients with Relapsed/Refractory Multiple
Myeloma (RRMM).
Part B: To evaluate the feasibility of isatuximab administered from a fixed infusion volume
in combination with Pd as assessed by occurrence of grade ≥3 infusion associated reactions
(IAR).
Secondary Objectives:
- To evaluate the infusion duration (Part B).
- To evaluate the safety profile of the combination with isatuximab administration from
fixed volume (Part B).
- To evaluate immunogenicity of SAR650984 in combination with Pd (Part A and B).
- To evaluate the pharmacokinetics (PK) of SAR650984 and its effect on the PK of
pomalidomide when administered in combination (Part A).
- To describe the efficacy of the combination of SAR650984 with Pd in terms of overall
response rate and clinical benefit rate based on International Myeloma Working Group
(IMWG) defined response criteria and the duration of response (Part A and B).
- To assess the relationship between clinical effects (adverse event [AE] and/or tumor
response) and CD38 receptor density at baseline (Part A).
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Graft versus host disease (GvHD) remains a major cause of morbidity and mortality related to
allogeneic stem cell transplantation. While improvements in immuno-suppressive regimens have
reduced the frequency and severity of acute GvHD, the incidence of chronic GvHD (cGvHD)
remains unchanged ranging from 30% after sibling matched related donor transplants to over
70% after unrelated donor bone marrow or peripheral blood stem cell transplant. Factors
associated with cGvHD include increased donor and recipient age, prior acute GvHD, and the
use of alloimmune female donors. Conventional therapeutic approaches for cGvHD, including
corticosteroids and immunosuppressive agents, have demonstrated limited efficacy in patients
with extensive disease and are associated with high toxicity.
Iterative extracorporeal photopheresis has demonstrated clinical and immunomodulatory
activity in subjects with acute and chronic GvHD. The currently available process of ECP has
not been controlled for cell number, exposure time, or specific cell populations targeted due
to the nature of the procedure. Using the Theralux procedure, defined populations of cells
may be targeted, and the intensity of photoactivating agent and exposure can be modulated to
achieve the maximal immunomodulatory effects in the treated subjects. This study will attempt
to explore the effects of the Theralux procedure under two defined conditions. Response and
toxicity will be determined at each intensity level and the dose associated with clinical
response and immunomodulatory effects on DC and NK cell populations will be defined as the
optimal intensity level for subsequent larger trials.
[/INST]
The purpose of this study is to assess the tolerability and safety of two intensity levels of
Theralux extracorporeal photochemotherapy in the treatment of subjects with steroid
refractory or intolerant GvHD.
The current hypothesis is that apoptotic cells re-injected into patients induce an
immunomodulation effect alleviating the GvHD symptoms. Using the Theralux procedure, the dose
of photodynamic treatment may be modulated to achieve the maximal immunomodulatory effects in
the treated patients.
The intervention is iterative extracorporeal photochemotherapy of autologous peripheral blood
mononuclear cells (PBMC) with a rhodamine-derivative TH9402 (drug) and Theralux (device).
</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/IIa - CANFOUR (BeNeLux/Scandinavia)[/INST]
This study will evaluate the safety, tolerability, and preliminary antitumor activity of
CAN04 both as a monotherapy and in combination with standard of care treatment in subjects
with solid cancer tumors.
Following completion of the first part, the dose escalation cohorts, and determination of
maximum tolerated dose or recommended phase 2 dose (MTD/RP2D), safety and tolerability will
be further evaluated in an expanded cohort of subjects with pancreatic or lung cancer, as
monotherapy or in combination with the standard of care treatment and to identify the RP2D of
CAN04 in combination with standard of care. In addition, early signs of efficacy during
treatment with CAN04 will be investigated.
</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 - ANDROMEDA (w/CyBorD)[/INST]
The purpose of this study is to evaluate the efficacy and safety of daratumumab plus
cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared with CyBorD alone in
treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
In the pivotal study that established that Herceptin® was highly effective when added to
standard chemotherapy in the front-line treatment of women with HER2 positive metastatic
breast cancer, benefit appeared to accrue to those patients whose tumors expressed the HER2
oncoprotein at the 3+ level by immunohistochemistry (IHC) or those patients whose tumors
demonstrated evidence of HER2 gene amplification by fluorescence in situ hybridization (FISH)
testing. Similarly, when Herceptin® was used as a single therapy in women with metastatic
breast cancer that had progressed following cytotoxic chemotherapy, 3+ overexpression of
HER2, but not 2+ expression, was associated with response to treatment. These and other
studies have led to the recommendation that Herceptin® should be administered to patients
with breast cancer whose tumors exhibit 3+ overexpression or gene amplification. This study
will evaluate whether treatment of patients with tumors that would not be expected to respond
to Herceptin® therapy, namely those that lack HER2 gene amplification and express the
oncoprotein at the 2+ level by IHC, may benefit from the use of the anti-HER2 monoclonal
antibody, MGAH22. If 5 or more responses are seen in 41 evaluable patients, then further
clinical development of margetuximab will be justified.
[/INST]
The purpose of this study is to determine if margetuximab is effective in the treatment of
certain patients with relapsed or refractory advanced 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 IIb - POWER 1 (TMC114-C213)[/INST]
The purpose of this study is to determine the antiviral activity, safety and tolerability of
TMC114, formulated as an oral tablet, and administered with a low dose of ritonavir
</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 - ELASCI[/INST]
Acute Spinal Cord Injury (SCI) is a rare injury that leads to permanent neuromotor impairment
and sudden disability. Approximately 25,000 people experience cervical SCI in the United
States, Europe, and Japan every year. The purpose of this study is to see if elezanumab is
safe and assess change in Upper Extremity Motor Score (UEMS) in participants with acute
traumatic cervical SCI.
Elezanumab is an investigational drug being developed for the treatment of SCI. Elezanumab is
a monoclonal antibody, that binds to an inhibitor of neuronal regeneration and neutralizes
the inhibitor, thus potentially promoting neuroregeneration. This study is "double-blinded",
which means that neither trial participants nor the study doctors will know who will be given
which study drug. Study doctors put the participants in 1 of 2 groups, called treatment arms.
Each group receives a different treatment. There is a 1 in 3 chance that participants will be
assigned to placebo. Participants 18-75 years of age with a SCI will be enrolled.
Approximately 54 participants will be enrolled in the study in approximately 49 sites
worldwide.
Participants will receive intravenous (IV) doses of elezanumab or placebo within 24 hours of
injury and every 4 weeks thereafter through Week 48 for a total of 13 doses.
There may be a higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the course of the study at a
hospital or clinic. The effect of the treatment will be checked by medical assessments, blood
tests, checking for side effects and completing questionnaires.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
The proposed phase II study is a single-center, randomized, double-masked, parallel-arm,
vehicle-controlled trial, designed to evaluate the safety and efficacy of Recombinant Human
Nerve Growth Factor (rhNGF) eye drops at 20 μg/ml concentration administered six times daily
for 8 weeks in patients with dry eye. After confirmation of inclusion and exclusion criteria
all eligible patients will be randomized at 2:1 ratio to rhNGF or vehicle control treatment
with 8 weeks of study treatments administration with 4 weeks Follow-up.
[/INST]
The primary objective of this study was to assess the efficacy and safety of rhNGF when
administered as eye drops to patients with dry eye
The secondary objectives of this study were:
- To assess change from baseline in Symptom Assessment In Dry Eye (SANDE) scores (without
imputation), corneal and conjunctival staining according to National Eye Institute (NEI)
scale, and in Tear Film Break-up Time (TFBUT) and Schirmer test I, following 4 and 8
weeks of treatment.
- To assess change in levels of inflammatory biomarker matrix metallopeptidase 9 (MMP-9)
in tears following 8 weeks of treatment.
- To assess the incidence and frequency of treatment-emergent adverse events (TEAEs)
following 8 weeks 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 II - Javelin Medley VEGF (w/Axitinib)[/INST]
This is a Phase 2 study to evaluate the safety and efficacy of avelumab in combination with
axitinib in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who have
received at least one prior platinum containing therapy, and in treatment naïve patients with
advanced or metastatic urothelial cancer, who are ineligible for cisplatin containing
chemotherapy for their advanced disease.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - NHL (Investigator Initiated)[/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 title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - AUAT-201[/INST]
This Phase 2, multicenter, randomized study will evaluate the safety, tolerability and
efficacy of ATI-501 for the treatment of Alopecia Areata (AA), Alopecia Universalis (AU) or
Alopecia Totalis (AT) in adult subjects.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - Adolescents[/INST]
This study will evaluate safety, tolerability, and immunogenicity of a booster dose of a
meningococcal vaccine formulation in adolescents.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - Study 015[/INST]
The purpose of this study is to determine if EVP-6124 (an alpha-7 nAChR agonist) enhances the
cognitive abilities of subjects with Schizophrenia who are also taking stable antipsychotic
therapy.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - TACTICS-HF[/INST]
The primary objective of this study is to compare the effects of oral Tolvaptan vs. placebo
as an adjunct to fixed dose IV furosemide on dyspnea relief in patients with acute
decompensated heart failure
The primary hypothesis is that the addition of oral Tolvaptan to fixed dose furosemide will
be more effective at relieving dyspnea than fixed dose furosemide 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 III - STARDOM2[/INST]
The MR308-3502 study is a multicenter double-blind, randomised, placebo- and active
comparator-controlled study in female subjects to evaluate the efficacy and safety of MR308
with acute pain after TAH or STAH (total or subtotal abdominal hysterectomy).
</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 - PoC (Males)[/INST]
In this proof-of-concept study, the safety and efficacy of a solution formulation will be
investigated in male subjects with androgenetic alopecia (AGA) after twice daily application
for up to 26 weeks.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I/II - ABY-035-001[/INST]
The purpose of this first-in-human study is to investigate the safety and tolerability of
ABY-035 when administered intravenously and subcutaneously, to healthy volunteers and to
psoriasis patients.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This Phase I/IIA, open label, multicenter, dose escalation study of CB-103 in patients with
Locally Advanced or Metastatic Solid Tumours and Haematological Malignancies. After providing
signed informed consent, patients will be screened for entry into the study. The study will
be conducted in 2 stages: dose escalation in Part A of the study (Phase I) followed by dose
expansion in Part B (Phase IIA).
Escalation cohorts will receive repeat doses of CB-103 to determine the MTD and RP2D.
CB-103 will be administered orally in treatment cycles of 28-days each. Aim of the expansion
Phase IIA, Part B of the study will be to collect preliminary evidence of anti-tumour
activity.
[/INST]
This is a phase I/II, non randomized, open-label, dose escalation study to investigate the
safety, tolerability and preliminary efficacy of CB-103.
</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 - PBI L606p3[/INST]
This Phase 3, 2-part, open-label, multicenter study aims to demonstrate the safety and
tolerability of L606 in patients with PAH or PH-ILD. The study will determine the short-term
and long-term safety and tolerability of L606 in this patient population; also evaluate the
steady-state pharmacokinetics (PK) of L606 as compared to Tyvaso, effects on exercise
ability, quality of life, and treatment satisfaction with L606.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
LN-145 is an adoptive cell transfer therapy that utilizes an autologous TIL manufacturing
process, as originally developed by the NCI. The cell transfer therapy used in this study
involves patients receiving a nonmyeloablative (NMA) lymphocyte depleting preparative
regimen, followed by infusion of autologous TIL followed by the administration of a regimen
of IL-2.
[/INST]
This study is a Phase 2, open-label, multicenter study evaluating adoptive cell therapy (ACT)
with autologous TIL therapy (LN-145) in combination with Anti-PD-L1 inhibitor durvalumab.
</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. Travatan[/INST]
The purpose of this study was to demonstrate that the intraocular pressure-lowering efficacy
of Travoprost 0.003% is equivalent to TRAVATAN® in adult patients with open-angle glaucoma or
ocular hypertension.
</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 Ib study conducted to determine the safety and tolerability of an IRX-2
regimen in ESBC, to be administered pre-operatively before standard-of-care surgical
resection and following standard-of-care diagnostic biopsy. This study will also include
triple-negative breast cancer patients who will receive the IRX-2 regimen prior to
chemotherapy.
Eligible subjects will have early stage breast cancer of any receptor sub-type, for which
standard-of-care surgical resection is planned. To be eligible, a minimum of 1 core of
tumor-bearing biopsy material must be available for research analysis.
Cohort B will enroll subjects triple negative breast cancer (defined by ER<10%, PR<10%, and
HER2-negative by NCCN guidelines), T1c+ tumors for which neoadjuvant anthracycline-based and
non-platinum containing chemotherapy is planned. The IRX-2 regimen will be administered and
completed preceding chemotherapy. Cohort B subjects must undergo post-IRX-2 Regimen biopsy
(2-3 cores), followed by commencement of chemotherapy preferably within one week after
biopsy.
The IRX-2 regimen will be administered in all enrolled subjects. IRX 2 will be administered
by subcutaneous injection into the periareolar skin of the affected breast.
[/INST]
The goal of this study is assess the safety and tolerability of the IRX-2 regimen in patients
with early stage breast cancer (ESBC) and to estimate the pathologic complete response rate
to neoadjuvant anthracycline-based and non-platinum containing chemotherapy in patients with
triple-negative breast cancer who have received the IRX-2 Regimen before 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 I - w/Paclitaxel & Carboplatin[/INST]
The purpose of this study is to test the safety of the investigational drug, selinexor
(KPT-330), in combination with carboplatin and paclitaxel chemotherapy, where paclitaxel will
be given at two different dosing schedules and selinexor will be given at two different
dosing schedules. Carboplatin and paclitaxel chemotherapy is a commonly used therapy for the
treatment of advanced or recurrent ovarian, fallopian tube, primary peritoneal, or
endometrial cancer. The investigators want to find out what effects, good and/or bad,
selinexor has on the patient and the cancer.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - MS-553-103[/INST]
A Phase I/II Dose-Escalation and Expansion Study Of The Selective PKC-Β Inhibitor MS-553 In
Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
</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 Vedolizumab. Vedolizumab is being tested to
treat pediatric participants who have moderately to severely active UC or CD.
This study will look at the long-term safety profile in participants who take vedolizumab IV.
Participants will continue receiving the same dose assigned from the parent study
MLN0002-2003 [NCT03138655], which will remain blinded until week 40.
The dosing regimen selected for the long-term study is intended to maintain clinical response
at the lowest possible exposure.
At the discretion of the investigator, participants receiving the low dose (150 or 100
milligram [mg]) of vedolizumab IV may be escalated to the high dose (300 or 200 mg) if the
participants demonstrate disease worsening at 2 consecutive visits (scheduled or
unscheduled).
Participants who experience continued disease worsening during the study despite being
administered vedolizumab 300 or 200 mg every 8 weeks (Q8W) will be discontinued from the
study.
Study duration will be until vedolizumab IV is commercially available for pediatric
indication(s) in the participant's country or until other drug access programs become
available (whichever comes first), the participant turns 18 years of age and can be
transitioned to commercial drug, the participant withdraws from the study, or the sponsor
decides to close the study (up to approximately 8 years).
[/INST]
The purpose of this study is to determine the safety profile of long-term vedolizumab IV
treatment in pediatric participants with UC or CD.
</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/IIa - Healthy Adults (Korea)[/INST]
The purpose of this study is to determine whether GC3110A (a QIV) is effective compared to GC
Flu Pre-filled Syringe Inj. (a marketed TIV) after single intramuscular administration in
Korean healthy adults.
The comparator, GC Flu pre-filled syringe inj. is a trivalent influenza vaccine (TIV)
including viruses representing 3 influenza strains (one A/HIN1, one A/H3N2, and one B).
However, two antigenically distinct lineages of influenza B (Victoria and Yamagata)
co-circulate annually in the United States. Predicting which lineage of influenza B will
predominate during a season is challenging, and cross-protection by immunization against the
other lineage is expected to be low. One proposed alternative is to produce a quadrivalent
influenza vaccine (QIV) including an influenza B virus from each of the two circulating
lineages. GC3110A is a new quadrivalent influenza vaccine (QIV), which contains all of 4
vaccine components WHO recommends for use in the 2013-14 influenza season (northern
hemisphere winter) and includes two influenza B viruses. GC3110A is expected to show the
additional public health benefit compared with traditional TIV.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Stage 1: This will be a 3+3 dose escalation to determine the DLTs and MTD/RP2D of APG-115
given according to the different dose levels once daily from Days 1 to 7 every 28 days.
Stage 2: After stage 1 of APG-115 single agent dose escalation first cycle is completed,
stage 2 can be initiated with the combination regimen. This will be a 3+3 dose escalation to
determine the MTD/RP2D and DLTs of APG-115 + AZA(arm A)/Cytarabine (arm B)combination.
Stage 3: dose expansion of the combination regimes.
[/INST]
Acute myeloid leukemia is a malignant disorder characterized by the rapid, uncontrolled
proliferation of malignant clonal hematopoietic stem cells that accumulate as immature,
undifferentiated cells (blasts) in the bone marrow and circulation.
APG-115 is a potent and orally active small-molecule MDM2 inhibitor, it binds to MDM2 protein
and shows potent cell growth inhibitory activity in vitro with low nanomolar potencies in a
subset of human cancer cell lines. APG-115 has demonstrated its strong antitumor activities
with either daily or less frequent dosing-schedules in the acute leukemia xenograft models.
This is a phase 1b, open-label, three-stages study that will initially evaluate the safety
and PK/PD profile of APG-115 as a single agent, followed by a combination of APG-115 +
azacytidine or cytarabine in R/R AML or MDS subjects.
Patients will continue treatment for maximally 6 cycles or until progression of disease or
unacceptable toxicity is observed or administrative discontinuation whichever occurs first.
Patients who continue to be benefit after 6 cycles' treatment will receive additional cycles
of treatment until progression of disease, unacceptable toxicity is observed or
administrative discontinuation. (As long as it is proven safe).
</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 - PIONEER 9 (vs. Placebo and vs. Liraglutide, Japanese Subjects)[/INST]
This trial is conducted in Asia. The aim of this trial is to investigate the dose-response
relationship of once-daily dosing of three dose levels (3, 7 and 14 mg) of oral semaglutide
versus placebo as monotherapy on glycaemic control in Japanese subjects 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 III - NGAM-08[/INST]
Study to evaluate the Efficacy and Safety of Three Different Dosages of NewGam in Patients
With Chronic Inflammatory Demyelinating Poly(radiculo)neuropathy
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
PRIMARY OBJECTIVE:
I. To determine the anti-tumor activity of combination therapy with CDX-1127 (varlilumab) and
nivolumab as compared to nivolumab alone in patients with advanced aggressive B-cell
non-Hodgkin lymphomas (NHL) based on the lymphoma response to immunomodulatory therapy
criteria or LYRIC.
SECONDARY OBJECTIVES:
I. To assess the safety and tolerability profile of treatment with a combination of CDX-1127
(varlilumab) and nivolumab in patients with advanced aggressive B-cell NHL.
II. To evaluate the duration of response, progression-free survival and overall survival.
EXPLORATORY OBJECTIVES:
I. To determine the effect of combination therapy with CDX-1127 (varlilumab) and nivolumab on
the immune system as assessed by immunohistochemistry (IHC), mass cytometry (CyTOF), changes
in serum cytokine profile and immunogenicity assays.
II. To describe the pharmacokinetic profile of CDX-1127 (varlilumab) and nivolumab when used
in combination.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive nivolumab intravenously (IV) over 30 minutes every 2 weeks for 4
months and every 4 weeks for a total of up to 2 years in the absence of disease progression
or unacceptable toxicity. Patients may cross over to Group II at the time of disease
progression.
GROUP II: Patients receive varlilumab IV over 90 minutes every 4 weeks for up to 2 years in
the absence of disease progression or unacceptable toxicity. Patients also receive nivolumab
IV over 30 minutes every 2 weeks for 4 months and every 4 weeks for a total of up to 2 years
in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 100 days.
[/INST]
This phase II trial studies how well nivolumab with or without varlilumab works in treating
patients with aggressive B-cell lymphomas that have come back (recurrent) or do not respond
to treatment (refractory). Immunotherapy with monoclonal antibodies, such as varlilumab and
nivolumab, may help the body's immune system attack the cancer, and may interfere with the
ability of tumor cells to grow and spread.
</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/Abemaciclib[/INST]
This is a Phase 1b, open-label, multicenter, dose-escalation study to evaluate the safety,
tolerability, pharmacokinetics (PK), and preliminary efficacy of ZN-c5 administered orally in
combination with abemaciclib (VERZENIO®) in participants with advanced estrogen-receptor
positive, human epidermal growth factor receptor-2 negative (ER+/HER2-) 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 II - +/-Spartalizumab (MET exon14)[/INST]
A double-blind, placebo controlled, randomized, phase II study evaluating the efficacy and
safety of capmatinib (INC280) and spartalizumab (PDR001) combination therapy versus
capmatinib and placebo as first line treatment for locally advanced or metastatic non-small
cell lung cancer (NSCLC) patients with MET exon 14 skipping (METΔex14) mutations
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
The study will be conducted at two sites and will include a minimum of 4 visits. The overall
study duration for participants will be approximately 8 weeks. Study participants will
undergo acute respiratory disease evaluation that will include a throat swab and a blood
draw. Each participant will also be contacted in six months for follow-up information.
[/INST]
This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the
safety and efficacy of oral DR-5001 in reducing the attack rate of febrile acute respiratory
disease caused by type-4 and type-7 adenovirus as well as determine its immunogenicity.
</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 - 023 Ext.[/INST]
This is a multicenter extension trial in adult hypogonadal males. The purpose of this study
is to evaluate the safety of testosterone gel delivered using an applicator over an extended
period of time.
</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 - 007 - vs. Prevnar 13[/INST]
This study is designed to assess the safety, tolerability, and immunogenicity of V114
compared with Prevnar 13™ in healthy adults 65 years of age or older previously vaccinated
with 23-valent pneumococcal polysaccharide vaccine.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Phase 1 Dose Escalation and Dose Expansion: To evaluate the overall safety profile,
characterize the PK profiles and assess the preliminary efficacy of TPX-0046 in adults
subjects with advanced solid tumors harboring oncogenic RET fusions or mutations.
Food Effect Sub-Study: To determine the effect of food on PK of TPX-0046 in adult subjects
with advanced or metastatic solid tumors harboring oncogenic RET fusions or mutations.
Phase 2 Efficacy Evaluation: To determine the overall safety and anti-tumor efficacy of
TPX-0046 in defined cohorts of subjects with advanced/metastatic solid tumors harboring
oncogenic RET fusions or mutations.
[/INST]
A phase 1/2, first-in-human, open-label study to determine the safety, tolerability, PK, and
preliminary efficacy of the novel RET/SRC inhibitor TPX-0046 in adult subjects with advanced
or metastatic solid tumors harboring RET mutations or alterations. The study consists of
three portions: 1) Phase 1 Dose Escalation and Food Effect Sub-study, and 2) Phase 1 dose
expansion and 3) Phase 2 efficacy evaluation.
</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 - Dose Re-Escalation[/INST]
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying the side effects and best dose of sorafenib and to
see how well it works in treating patients with advanced malignant solid tumors.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - M10-883 (Peripheral Spondyloarthritis)[/INST]
The objective of this study was to evaluate the efficacy and safety of adalimumab 40 mg
administered every other week (eow) subcutaneously (SC) compared to placebo for 12 weeks
followed by open label (OL) safety and efficacy assessments in participants with
non-ankylosing spondylitis (AS), non-psoriatic arthritis (PsA) active peripheral
spondyloarthritis (SpA) who have had an inadequate response to >= 2 non-steroidal
anti-inflammatory drugs (NSAIDs), or are intolerant to, or have a contraindication for,
NSAIDs.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This study is a 13 week (91 days) randomized, double-blind, in home use study among 30 male
and female subjects with moderate to severe active atopic dermatitis (AD). The study will
include subjects with ages 12 - 65 years old inclusive. Group assignments will be balanced by
age and disease severity of AD. The study will consist of a 1 week washout period and 12 week
treatment phase. During the treatment phase, subject will be provided one of the two test
products to use twice daily on all lesions and non-lesional areas as instructed. No
additional creams, lotions or soaps other than provided test products will be allowed
throughout the duration of the study. Measurements, expert visual assessments and
self-assessments will be taken as described below. Safety and tolerability will be evaluated
by incidence of AE's (defined per CTCAE), exacerbations, application site
reactions/infections, and lab evals. There will also be consumption/compliance checks and
dermatological evaluations at each visit.
[/INST]
Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by a disturbance
of epidermal-barrier function that results in intensely pruritic subacute and chronic
eczematous plaques. The current therapy of AD is reactive, where the flares are treated
through symptomatic management with topical corticosteroids and calcineurin inhibitors. Given
that these medications have long-term side-effects, and given the chronically relapsing
immunopathogenic nature of AD, there is an imperative need for safer anti-inflammatory
medications. Haus Bioceuticals (Haus) has developed a novel topical treatment for
eczema/atopic dermatitis (AD) denoted HAT01H, and have demonstrated that HAT01H is safe and
profoundly effective in the treatment of AD, controlling signs and symptoms in 85% of
patients with AD. This study is aimed to further test the efficacy and safety of topical
HAT01H in patients with moderate to severe atopic dermatitis.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - Pediatric[/INST]
A phase one study to characterize the pharmacokinetics of dalbavancin in pediatric patients
aged 3 months to 11 years (inclusive) following the intravenous administration of a single
dose of dalbavancin.
</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 - Elderly Patients[/INST]
To assess the efficacy of Vortioxetine (5 mg daily) versus placebo in the acute treatment of
depression by means of the change from baseline in the 24-item Hamilton Depression Scale
(HAM-D24) total score after 8 weeks of double-blind treatment in elderly patients.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - C-EDGE IBLD[/INST]
This is a randomized, multi-site, placebo-controlled trial of a fixed dose combination (FDC)
of grazoprevir (MK-5172) 100 mg + elbasvir (MK-8742) 50 mg in participants with chronic
Hepatitis C Virus (HCV) genotype (GT) 1, GT4 or GT6 with inherited blood disorders. The
primary hypothesis is that the proportion of participants treated with grazoprevir+elbasvir
achieving Sustained Virologic Response (SVR) 12 weeks after the end of all study therapy
(SVR12) will be greater than the reference rate of 40%.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Currently, the most widely used drugs to treat pain after surgery are opiates, such as
morphine. Morphine works mainly by activating one of several types of opiate receptors that
control some of our pain sensation - the so-called mu opiate receptors. These receptors are
located in many areas of the brain and also outside of the brain. By activating these
receptors, morphine provides significant pain relief, but also causes side effects that limit
its use. Some of these side effects include: respiratory depression or arrest (slowed or
stopped breathing), sedation (a state of calmness or extreme relaxation), euphoria (an
exaggerated feeling of physical and mental well-being), constipation, nausea, vomiting, and
drug addiction.
In order to avoid the side effects of morphine and other mu opiates, the present experimental
drug CR845 was designed to work at a different type of opiate receptor - called kappa - that
can also provide pain relief, by acting on sensory nerves outside the brain. CR845 was
designed to penetrate the brain much less than other opiate drugs, which should result in
pain relief similar to that of morphine, but with fewer side effects. Because CR845 activates
kappa receptors instead of mu receptors, the side effects are different than with a
morphine-type drug. In particular, kappa opiates, such as CR845, do not cause respiratory
depression or arrest, euphoria, constipation, drug tolerance, physical drug dependence or
drug addiction. For these reasons, CR845 may present a distinct advantage over other opiates
that are currently used for pain relief and post-operative pain in particular.
[/INST]
The primary purpose of this study is to determine if CR845 is effective in treating the pain
associated with a laparoscopic hysterectomy.
</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 - ALPINE (vs. Invega Sustenna)[/INST]
This study will evaluate the efficacy of initiating treatment of schizophrenia with ARISTADA
INITIO plus 30 mg oral aripiprazole followed by a 2-month dose of AL.
</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 - V98P2 (Switzerland)[/INST]
The goals of the proposed study are to evaluate the safety, tolerability and immunogenicity
of a GBS vaccine. Previous studies suggest that immune responses against GBS can protect
humans from 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 I - BrTK01 (GBM/AA)[/INST]
This phase I study evaluated a Gene Mediated Cytotoxic Immunotherapy approach for malignant
gliomas, including glioblastoma multiforme and anaplastic astrocytoma. The purpose of this
study was to assess the safety and feasibility of delivering an experimental approach called
GliAtak which uses AdV-tk, an adenoviral vector containing the Herpes Simplex thymidine
kinase gene, plus an oral anti-herpetic prodrug, valacyclovir, in combination with standard
of care radiation.
</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 - 1346.4 (Korea)[/INST]
To investigate the safety, tolerability and pharmacokinetics of BI 425809 tablets in healthy
Chinese and Japanese male subjects following the administration of single rising oral doses
and further to explore the pharmacokinetics (PK) including dose proportionality of BI 425809
after single dosing of product.
</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[/INST]
In Phase 1 of this study, the purpose is to evaluate the safety, tolerability, and highest
safe dose of the multiple receptor tyrosine kinase inhibitor (including VEGFR2, MET, and RET)
XL184 in combination with the EGFR inhibitor erlotinib administered to adults with
Non-Small-Cell Lung Cancer (NSCLC). In Phase 2 of this study, the purpose is to evaluate the
objective response rate of daily oral administration of XL184 with or without erlotinib in
subjects with NSCLC who have progressed after responding to treatment with erlotinib.
</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 - PK[/INST]
This is a multi center, open label, parallel group, single administration, phase I trial, in
subjects with mild, moderate or severe renal impairment and a control group with normal renal
function.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase III - China[/INST]
In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of
pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome
information of a novel coronavirus (SARS-CoV-2) from these pneumonia patients and developed a
real-time reverse transcription PCR (real-time RT-PCR) diagnostic assay.
Given no specific antiviral therapy for COVID-19 and the ready availability of remdesvir as a
potential antiviral agent, based on pre-clinical studies in SARS-CoV and MERS-CoV infections,
this randomized, controlled, double blind trial will evaluate the efficacy and safety of
remdesivir in patients hospitalized with severe COVID-19.
</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 - vs. Doripenem[/INST]
This is a study in adult subjects with complicated urinary tract infection (cUTI) comparing
treatment with intravenous (IV) coadministered ceftaroline fosamil and NXL104 versus
treatment with IV doripenem.
</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 - EMERALD[/INST]
The purpose of this study is to evaluate the change in serum potassium levels from start of
treatment to Day 14, when patiromer is administered at different doses, once daily, in
children 2 - < 18 years of age with chronic kidney disease (CKD) and hyperkalemia (too much
potassium in the blood). Another purpose of the study is to evaluate the safety and
tolerability of patiromer in children 2 - < 18 years of age with CKD and hyperkalemia.
</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 - 02 [/INST]
This study will evaluate the safety of autologous T cells that have been immunized ex vivo
with patient-specific MDS stem cell neoantigens in patients with MDS.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II - TCD11418 (w/Gemcitabine/Carboplatin) (Triple Negative)[/INST]
Primary Objective:
- To assess the objective response rate (ORR) of iniparib (SAR240550) administered as a
60min intravenous (IV) infusion twice weekly or weekly, in combination with
gemcitabine/carboplatin chemotherapy regimen in patients with metastatic Triple Negative
Breast Cancer (mTNBC).
Secondary Objectives:
- To assess the clinical benefit rate (CBR) defined as the rate of complete response (CR),
partial response (PR) and stable disease (SD) lasting at least 24 weeks;
- To assess Progression-free survival (PFS) and the overall survival (OS);
- To assess the safety profile of each schedule of iniparib;
- To assess the biological activity in tumor tissue (substudy);
- To evaluate the pharmacokinetic (PK) profile of iniparib (substudy);
- To characterize molecular and biological profile of tumors (substudy);
- To assess the effect of iniparib on poly(ADP)-ribose (PAR) level in peripheral blood
mononuclear cells (PBMC) (substudy).
</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 - 3842[/INST]
This trial is conducted in Europe. The aim of the trial is to evaluate the change in disease
activity following intravenous (i.v.) administration of two doses of NNC0114-0006 compared to
placebo in subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX)
therapy.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
The Part I (Phase 1a) assessments of the dose-related safety and PK of NVR 3-778 in
volunteers will be conducted an established Phase 1 unit, which will facilitate the overnight
confinements and frequent safety assessments and blood sampling required for the Part I
evaluations. The Part II (Phase 1b) assessments of the dose-related safety, PK, and initial
antiviral efficacy of NVR 3-778 in hepatitis B patients will also be conducted at
approximately 14 different sites to meet enrollment goals of 54-84 chronic hepatitis B
patients.
To promote objective safety and tolerance assessments during this trial, study subjects, and
site personnel administering the study drug and performing the clinical assessments on the
subjects, will be blinded to individual subjects' treatments assignments (active NVR 3-778 or
placebo doses), for all treatment cohorts in the study. Study advancement to subsequent
volunteer cohorts in Part I and subsequent patient cohorts in Part II will require
satisfactory interim reviews of available cumulative safety data by the Part I and Part II
Safety Review Committees (SRCs), using the safety criteria and review procedures described in
the protocol. Also, there will be two interim reviews of safety data by an independent Safety
Monitoring Board (SMB), as described in the protocol.
[/INST]
This Phase 1 trial will assess the dose-related safety and PK profile of different doses of
NVR 3-778, first in healthy volunteer subjects (part I) and subsequently in patients with
chronic hepatitis B (part II). Additionally, in Part II, changes in patients' serum HBV DNA
levels and other virologic efficacy parameters will 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 III - MAVORIC (vs. Vorinostat)[/INST]
The purpose of this study is to compare the progression free survival of KW-0761 versus
vorinostat for subjects with relapsed or refractory CTCL.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
This study will test the hypothesis that the vasodilation associated with capsaicin-induced
dermal blood flow (DBF) provides a good model for the vasodilation associated with hot
flashes; therefore erenumab doses that cause DBF inhibition will be safe and well tolerated,
and will be effective in the reduction of the frequency and/or severity of HFs.
[/INST]
The primary objective of this study was to evaluate the frequency of moderate to severe daily
hot flashes 4 weeks after a single dose of erenumab (AMG 334) in women with hot flashes
associated with menopause.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Although chronic ART raises cluster of differentiation CD 4+ T cell counts and improves
immune function, the immune systems' ability to control HIV-1 replication is not improved.
AGS-004 is an immunotherapeutic agent made from autologous DCs co electroporated with
amplified in vitro transcribed (IVT) ribonucleic acid (RNA) encoding CD40L and with IVT RNA
encoding three or four autologous HIV-1 antigens. The HIV-1 RNA is derived from the plasma
sample taken immediately prior to the initiation of ART.
[/INST]
The purpose of this study is to examine the ability of AGS-004 to control HIV-1 replication
and to determine if HIV-1 immunotherapy made with dendritic cells is safe and well tolerated,
to determine if immunotherapy increases the body's immune response to HIV-1; and, to
determine if after stopping anti-HIV drugs, immunotherapy can control the HIV-1 virus.
</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 - Primary Open-angle Glaucoma (SAD)[/INST]
This is a multi center, open-label, single dose, safety study. Approximately 9 to 15
participants with open-angle glaucoma are assigned into 3 sequential dose-levels and will
receive ANX007 administered as single, IVT injections.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Subjects will undergo surgical transplantation of the dopamine-producing cells under general
anesthesia into a part of the brain called the putamen. Subjects then take medicines to
partially suppress their immune system (aimed to prevent the body from rejecting the cells)
for 1 year. Safety, tolerability, evidence of cell survival (using MRI and PET scans of the
brain), and effect on Parkinson's disease symptoms are assessed for 2 years post-transplant.
[/INST]
This clinical trial is designed to test whether surgically injecting nerve cells that make
dopamine into the brain of Parkinson's disease patients is safe, and to monitor for potential
side effects.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
All patients will be treated with eltrombopag for the 26-week Treatment Period, followed by a
52-week Follow-Up Period. Patients who have been previously untreated with immunosuppressive
therapy will be treated according to the standard of care, hATG/cyclosporine, in addition to
eltrombopag. Patients with relapsed/refractory SAA or recurrent AA will be enrolled into one
of two treatment options: hATG/cyclosporine plus eltrombopag or cyclosporine plus
eltrombopag, depending on prior treatment with immunosuppressive therapy.
After initiating treatment with eltrombopag, patients will have their dose assessed and
modified as tolerated, until the targeted platelet count or maximum dose is achieved.
Pharmacokinetic assessments will be performed at time points intended to capture steady state
PK of the starting dose and highest dose achieved.
There are four separate periods of this study: Screening (signing of written informed consent
through Day -1), Treatment (for 26 weeks), Follow-up (additional 52 weeks), and Long-term
Follow-up (for additional 3 years). The first 3 periods will be considered the Core phase of
the study.
Study completion (Core) will occur when the last patient completes the 26-week treatment and
52-week Follow-up Period [at Week 78].
[/INST]
This is a phase II, open label, multi-center, intra-patient dose escalation study to
characterize the pharmacokinetics (PK) after oral administration of eltrombopag in
combination with immunosuppressive therapy in pediatric patients with previously untreated or
relapsed/refractory severe aplastic anemia or recurrent aplastic anemia.
</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 - MDS and MF[/INST]
This study enrolls patients with myelodysplastic syndrome (MDS) and myelofibrosis (MFS), with
transfusional iron overload and treats them with the investigational iron chelator, SP-420.
SP-420 may be better tolerated and safer than commercially available iron chelators. Iron
chelation therapy (ICT) has been shown to improve outcomes in iron overload, but adherence is
poor due to problems related to ease of administration, tolerability, and safety.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Early in the COVID-19 pandemic, it became apparent that the elderly are disproportionately
bearing the burden of disease and mortality. Many outbreaks are occurring in long-term care
homes (LTCHs), with strikingly high mortality rates: nearly two-thirds of all Canadian COVID-
19 deaths are in LTCH residents. This is unsurprising, as viral respiratory outbreaks in
LTCHs are devastating: before the use of influenza vaccine, case fatality rates during
influenza outbreaks were as high as 55%. Interventions are thus urgently needed to control
LTCH outbreaks to mitigate harms to this vulnerable population and maximize acute care
capacity.
Chemoprophylaxis is the cornerstone of management of LTCH influenza outbreaks and disease
prophylaxis has been deemed a critical COVID-19 research priority by the World Health
Organization. While definitive therapies do not yet exist, there is significant interest in
repurposing existing anti-viral agents against COVID-19. Favipiravir, a broad spectrum
antiviral agent, demonstrates activity against SARS-CoV-2 in vitro, and was associated with
faster viral clearance, radiographic improvement, and clinical recovery in early trials.
Favipiravir is an ideal candidates for chemoprophylaxis, as it is orally available and has a
reasonable safety profile.
To address the need to intervene to prevent the spread of COVID-19 in LTCHs, we propose a
cluster-randomized placebo-controlled trial of chemoprophylaxis in LTCHs experiencing
COVID-19 outbreaks.
This study is a partially blinded, placebo-controlled cluster randomized trial of
chemoprophylaxis to control outbreaks of COVID-19 in LCTHs for the elderly. The unit of
analysis is a ward/unit. An outbreak is defined as ≥ 2 symptomatic
microbiologically-confirmedCOVID-19 cases within 7 days on the LTCH unit. This design is
selected to mimic the current approach to outbreaks of other respiratory viral infections,
both because this approach has proven effective for these other viruses, and because it is
standard practice and therefore feasible to implement.
Eligible LTCHs will be asked to report outbreaks to the study in addition to the
legally-required reporting to their local public health unit; public health units will also
be asked to discuss the study with LTCHs reporting outbreaks. In addition, study staff will
contact the infection control practitioner in each of the screened LTCHs twice weekly, to
ensure the prompt identification of outbreak units.
Residents and staff will be assessed for contraindications to enrollment and informed consent
will be obtained for residents and staff to receive the allocated intervention, and to be
followed up individually for clinical outcomes, adherence and safety during the outbreak.
LTCH units experiencing an outbreak of COVID-19 will be randomized to either favipiravir or
placebo in a 1:1 ratio. Favipiravir or placebo will be offered to all residents and staff who
will be working on the unit during the chemoprophylaxis period, according to the allocation.
Study drug will continue for a duration of 25 days. The dosage for favipiravir to be used in
this study for chemoprophylaxis is 1600 mg (8 x 200 mg tablets) orally twice daily on day 1
followed by 800 mg (4 x 200 mg tablets) orally twice daily on day 2-25. Residents in the LTCH
unit diagnosed with COVID-19 at enrollment will be offered treatment with favipiravir or
placebo for 14 days, according to the LTCH unit allocation. The dose of favipiravir for
treatment is 2000mmg orally twice daily on day 1, then 1000 mg orally twice daily for 13
additional days.
Surveillance for infection will occur as usual for resident illness within each LTCH; staff
will be asked to report symptoms and will be screened for symptoms each time they enter the
building. Consenting residents and staff will be screened at day 0, day 14 and day 40 to
identify asymptomatic infections and to assess duration of viral shedding. The primary
outcome will be control of the outbreak, defined as no new microbiologically confirmed case
of COVID-19 for 24 consecutive days up to day 40.
[/INST]
To address the need to intervene to prevent the spread of COVID-19 in long-term care homes,
we propose a randomized clinical trial of chemoprophylaxis in long-term care homes
experiencing COVID-19 outbreaks. LTCH units experiencing an outbreak of COVID-19 will be
randomized to chemoprophylaxis with favipiravir or placebo in a 1:1 ratio.
Chemoprophylaxis in this setting refers to the use of favipiravir for pre-exposure
prophylaxis, post-exposure prophylaxis, pre-emptive therapy, or treatment for established
COVID-19. This design mimics the approach to influenza outbreaks, which has proven efficacy
for outbreak control. The primary outcome will be control of the outbreak, defined as no new
microbiologically confirmed case of COVID-19 for 24 consecutive days up to day 40.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Study TDE-HF-302 was a multicenter, open-label study in subjects participating and completing
all required visits for Study TDE-HF-301. This study assessed the long-term safety of oral
treprostinil in subjects with PH associated with HFpEF.
Subjects received oral treprostinil as 0.125-, 0.25-, 1-, and 2.5-mg sustained-release
tablets. For subjects who were randomly allocated to receive oral treprostinil in Study
TDE-HF-301, the initial dose of oral treprostinil was the same as the final dose in Study
TDE-HF-301. Subjects randomly allocated to receive placebo in Study TDE-HF-301 were
administered the initial dose of oral treprostinil at 0.125 mg 3 times daily (TID). Dose
increases could occur in 0.125-mg increments every 72 hours at the discretion of the
Investigator up to 6 mg TID, the maximum allowable dose determined by the Data Monitoring
Committee during Study TDE-HF-301. Doses of study drug were to be increased in the absence of
dose-limiting drug-related adverse events (AEs) to ensure that each subject received the
optimal dose throughout the study. Subjects returned for visits at Weeks 6, 12, 18, and 24,
and every 12 weeks thereafter. Subjects who terminated the study early were asked to return
to the study center for a final evaluation.
Safety assessments consisted of AEs, clinical laboratory parameters, and clinical assessment
of heart failure signs and symptoms.
Due to the lower than expected number of subjects enrolled, the planned secondary
efficacy-related endpoints were not analyzed.
[/INST]
This was an open-label study to evaluate the safety of continued therapy with oral
treprostinil in subjects who completed Study TDE-HF-301. This study provided long-term,
open-label data regarding the effect of continued long-term oral treprostinil therapy for the
treatment of pulmonary hypertension (PH) associated with heart failure with preserved
ejection fraction (HFpEF). Subject visits occurred at Baseline, Weeks 6, 12, 18, 24, and
every 12 weeks thereafter until either oral treprostinil was commercially available to treat
PH associated with HFpEF or the study was discontinued by the Sponsor.
The Sponsor terminated Studies TDE-HF-301 and TDE-HF-302 on 14 October 2019 due to slow
enrollment. Safety data from the final subject in Study TDE-HF-302 were recorded on 02 March
2020. Due to the lower than expected number of subjects enrolled, the planned secondary
efficacy-related endpoints were not analyzed.
</s> |
<s>[INST]<<SYS>>You are given the full description of a clinical trial. Summarize it to short paragraph.<</SYS>>
Annual influenza epidemics are associated with serious excess morbidity and mortality,
particularly among the elderly. Licensed trivalent inactivated influenza vaccines (TIVs) have
been shown to reduce hospitalization and death following influenza in this vulnerable
population, but their efficacy is lower than that observed in younger, healthy populations.
In addition, recent studies have questioned the level of effectiveness of TIV in the elderly,
suggesting that cohort studies have overestimated the benefits of immunization with current
TIV formulations in this age group. In view of these considerations, it is widely accepted
that improved and alternative vaccines are needed for control of seasonal and pandemic
influenza.
Currently available TIVs are prepared from viruses that are grown in embryonated hens' eggs.
Alternative substrates for vaccine production are desirable in order to reduce the
vulnerability of and to expand influenza vaccine supply. Recombinant DNA techniques allow for
expression of the influenza hemagglutinin (rHA) by baculovirus vectors in insect cell
cultures. Advantages of this technique include speed of production, absence of egg protein,
and a highly purified product. Previous studies among healthy younger and older adults have
confirmed that rHA vaccines are safe, well tolerated and immunogenic at dosages up to nine
times higher than those contained in TIV. Dose-related increases in serum antibody levels
after immunization also were observed.
[/INST]
The purpose of this study were to obtain additional evidence in support of the safety and
immunogenicity of a recombinant hemagglutinin (rHA) vaccine in an elderly population, and to
establish non-inferiority of the immunogenicity of the rHA vaccine when compared with a
licensed trivalent influenza vaccine (TIV). Another purpose was to provide a preliminary
estimate of the relative efficacy of the two vaccines against culture-positive influenza-like
illness during the subsequent epidemic.
</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 - RADICAL[/INST]
This study is looking at a new drug called AZD4547 which is being tested for the treatment of
oestrogen receptor positive breast cancer. AZD4547 is a drug which specifically "blocks"
proteins called fibroblast growth factor receptors (FGFR1) that are involved in the processes
that help cancer cells to grow. These proteins may also be responsible for the development of
resistance to hormonal therapies used to treat some breast cancers. AZD4547 is not yet
approved for use in breast cancer and is therefore being used in this study as a research
drug.
The investigators will also test the theory that it is not necessary for high levels of FGFR1
to be present in the body to see benefit from AZD4547. (Stage 1 only)
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - HT-003-01[/INST]
Choline alfoscerate(L-alfa glycerylphosphorylcholine) is a natural compound found in the
brain and breast. Choline alfoscerate contains 40.8% of choline and has a produrig structure
and separated by a precursor of choline and nerve cell membrane precursor of acetylcholine
glycerophosphate. Choline alfoscerate Colin normalization of nerve pathways, nerve cell
membrane play and acetylcholine receptor function secondary symptoms caused by
cerebrovascular deficiency and indirectly through activation of metabolism, has a
degenerative effect on the brain organic mental syndrome.
Currently marketed oral choline alfoscerate received a geriatric cognitive impairment,
secondary symptoms and degeneration, or soft capsule is authorized to prescription drugs for
degenerative brain organic mental syndrome caused by cerebrovascular deficiency. Gliatilin
soft capsules containing 400 mg per 1 capsule 2-3 times one days're supposed to take when
considering optimal convenience and efficiency of the drug in patients with the development
of sustained release formulations that can be maintained for a long period of time, a certain
concentration is required. Accordingly, the modern drug by reducing the frequency of
administration a day circuit is to develop a sustained release formulation of choline
alfoscerate HT-003 600 mg medication compliance for the purpose of raising. 2 tablets at a
time (600 mg x 2) can be taken one day to 1200 mg is required by taking.
Therefore, for the development of sustained release formulation, the test in healthy adult
male volunteers targets choline alfoscerate soft capsule formulation of 400mg 3 times per 1
day and sustained-release tablet 600mg 2time per 1 day, pharmacokinetic properties and safety
of a single dose should be evaluated when compared.
</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 - DEMAND I (DMD114118; Non-Ambulant Pts)[/INST]
The purpose of this study is investigate the pharmacokinetics, safety and tolerability of
single subcutaneous administration of GSK2402968 in non-ambulant boys with Duchenne muscular
dystrophy
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase I - w/Letrozole or Exemestane (HR+)[/INST]
The purpose of this study is to test the safety of a drug called BYL719 at different dose
levels. The investigators want to find out what effects, good and/or bad, BYL719 has on the
patient and breast cancer. BYL719 will be given with either letrozole or exemestane to
patients with HR+ locally-advanced or metastatic breast cancer. When the recommended phase II
dose of BYL719 in combination with letrozole or exemestane has been determined in the
dose-finding phase, an additional 10 patients will be enrolled onto each arm in an expansion
phase of the study. The purpose of the expansion phase is to further define the safety and
feasibility of BYL719 in combination with letrozole or exemestane at the recommended phase II
dose, and to estimate efficacy.
</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 - HIV Uninfected Chinese Men[/INST]
The pre-exposure prophylaxis (PrEP) is an important component in the overall strategy for
prevention of HIV infection. Cabotegravir (CAB) is an integrase strand transfer inhibitor
currently in development for treatment and prevention of HIV infection. CAB possesses
attributes that allow formulation and delivery as a LA parenteral product. CAB is being
developed as both oral and long acting (LA) injectable formulations. This study is designed
to evaluate the PK, safety, tolerability, and acceptability of CAB LA in adult HIV uninfected
Chinese male subjects at low risk for HIV acquisition. Eligible subjects will receive oral
CAB during oral phase of the study followed by CAB LA intramuscular (IM) injection during
injection phase of the study. Approximately 60 subjects will be screened, of which,
approximately 48 subjects will enter the oral phase and 40 subjects will enter the injection
phase of the study. The maximum study duration will be approximately 89 weeks including oral
phase, injection phase and follow-up phase.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II[/INST]
The primary objective of this study is to determine the optimum once daily dose of BI 1744 CL
and tiotropium in free dose combination (delivered by the Respimat inhaler) after four week
treatment in patients with 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 I/II - w/Paclitaxel or Pembrolizumab[/INST]
This is a first-in-human, Phase 1/2 multi-center, open-label, dose escalation and expansion
study of AO-176 which will evaluate the safety, tolerability, pharmacokinetics (PK),
pharmacodynamics, and clinical effects of AO-176 in patients with advanced solid tumors.
</s> |
<s>[INST]<<SYS>>You are given the title of a clinical trial. Write a brief description that matches the trial title.<</SYS>>Phase II/III - Ocular GVHD[/INST]
This clinical study seeks to evaluate the safety and efficacy of Pro-ocular™1% topical gel in
patients with ocular Graft-versus-Host Disease who wear scleral lenses daily. This
vehicle-controlled trial will evaluate the investigational drug's effect on signs and
symptoms of ocular Graft-versus-Host Disease and on the hours of daily comfortable and
serviceable scleral lens wear.
</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 - EVERHEART[/INST]
The purpose of this study, in de novo heart transplant patients, is to evaluate whether
delayed introduction of everolimus reduces the occurrence of wound healing problems,
pericardial and/or pleural effusion and early acute renal insufficiency, as compared with
immediate introduction of everolimus, in the firs six months after heart 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 - SAD (Healthy Volunteers; UK)[/INST]
This is a randomised, double-blind, placebo-controlled and ascending single dose study. It is
hypothesised that single oral doses of DS-1971a within the planned dose range will be safe
and well tolerated by healthy male 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 - Healthy Volunteers (001)[/INST]
This is a randomized, double-blind, placebo-controlled study of single and multiple ascending
dosage levels of AZD8108 in healthy volunteers. The study includes an up to 28-day screening
period, an in-house period during which AZD8108 or placebo will be administered orally as a
solution, and a 4- to 10-day follow-up period after discharge.
</s> |