bioihbjkbjnl/mcl2 huggingface dataset:
Patient-individualized Peptide Vaccination Based on Tumor-specific Mutations in Children and Young Adults With Primary/Relapsed ALL
Condition: Primary/Relapsed Acute Lymphoblastic Leukemia (ALL) of Childhood, Adolescents and Young Adults
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this clinical study is to evaluate the feasibility and safety of an individualized
      peptide vaccination approach in patients with acute lymphoblastic leukemia (ALL). For this
      purpose, tumor-specific mutations are analyzed by comparative exome sequencing of tumor and
      healthy reference tissue. Expression of variants is further validated by RNA sequencing. In a
      second step, HLA-binding (human leukocyte antigen-binding) peptides derived from mutated
      protein sequences are selected for vaccination. The peptides are administered as a
      vaccination cocktail with adjuvant GM-CSF and Imiquimod over a course of 9 months and a total
      of 16 vaccinations. Primary objective is the de novo induction of a specific T cell response
      without unacceptable toxicity and acute GvHD (graft versus host disease).
    


Intervention name(s): Individual peptide vaccination with adjuvant GM-CSF and Imiquimod
Intervention type(s): Biological
Intervention description(s): Intradermal injection of a cocktail of 3-5 individual HLA-binding peptides. Subcutaneous injection of adjuvant GM-CSF at vaccination site. Topical administration of Imiquimod at vaccination site.
Intervention MeSH terms: Imiquimod
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Individualized peptide vaccination; Immunotherapy; Tumor-specific mutations; Neoantigens
Trial of Safety and Efficacy of Rasagiline in Patients With Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis (ALS)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      ALS is a disorder that weakens motor strength and lung function. Rapid loss of motor neurons
      in the brain and spinal cord of ALS patients causes the symptoms of increasing weakness and
      loss of muscle function. While there are drugs to help relieve symptoms of ALS, there is no
      cure for ALS.

      Rasagiline is a drug with possible neuroprotective characteristics. Neuroprotective means
      that the nervous system may be protected against weakening. It is known that rasagiline has
      possible neuroprotective characteristics and it is approved for use for patients with another
      disorder, the effectiveness of rasagiline for patients with ALS has not been tested.
    

Detailed description: 
      The specific aim of this screen study is to determine whether rasagiline is safe in this
      patient population and if the drug has the potential to slow ALS disease progression
    

Intervention name(s): rasagiline
Intervention type(s): Drug
Intervention description(s): rasagiline 2 mg daily for 12 months
Intervention MeSH terms: Rasagiline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pegylated Arginine Deiminase in Treating Patients With Metastatic Melanoma That Cannot Be Removed by Surgery
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Pegylated arginine deiminase may stop the growth of tumor cells by taking away an
      amino acid needed for cell growth.

      PURPOSE: This phase II trial is studying how well pegylated arginine deiminase works in
      treating patients with metastatic melanoma that cannot be removed by surgery.
    

Detailed description: 
      OBJECTIVES:

      Primary:

        -  Determine the clinical response (complete and partial response) in patients with
           unresectable metastatic melanoma treated with pegylated arginine deiminase.

      Secondary:

        -  Determine the toxicity profile of this drug in these patients.

        -  Determine the pharmacokinetics and pharmacodynamics of this drug in these patients.

        -  Determine the progression-free survival and overall survival of patients treated with
           this drug.

      OUTLINE: Patients receive pegylated arginine deiminase intramuscularly once or twice a week
      in weeks 1-4. Courses repeat every 4 weeks for 6 courses in the absence of disease
      progression or unacceptable toxicity.

      Blood samples are acquired at baseline and every 2 weeks thereafter for pharmacokinetic and
      pharmacodynamic studies.

      After completion of study treatment, patients are followed every 3 months for 1 year, every 6
      months for 5 years, and annually thereafter.

      PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.
    

Intervention name(s): ADI-PEG-20; Pharmacology Studies
Intervention type(s): Biological; Other
Intervention description(s): There will be 6 cycles planned, each consisting of 4 weeks. During each cycle subjects will receive injections on days 1, 8, 15, and 22 + 2 days. All subjects may begin treatment with 160 IU/m2 on a weekly basis.; tissue blocks will be obtained from the initial biopsy of melanoma. Immunohistochemical staining for ASS and RT-PCR will be performed on the tumor tissue
Other intervention name(s): Arginine Deiminase (ADI) formulated with polyethylene glycol (PEG)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent melanoma; stage IV melanoma
Progevera 10 mg® Versus Orgalutran® in Ovarian Stimulation Cycles of Oocyte Donors
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluation of efficacy and safety of medroxiprogesterone acetate (Progevera 10 mg®) versus
      GnRh antagonist (Orgalutran®) in ovarian stimulation cycles of oocyte donors
    


Intervention name(s): Progevera; Orgalutran
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ganirelix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild-to-moderate Asthma and in Healthy Volunteers
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, first-in-human (FIH), multi-center, randomized, double-blind,
      placebo-controlled study of CSL311 in patients with mild-to-moderate asthma. The primary
      objective of this study is to assess the safety and tolerability of single ascending doses
      (SAD) and multiple ascending doses (MAD) of CSL311.
    


Intervention name(s): Human beta common receptor antagonist monoclonal antibody; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Human beta common receptor antagonist monoclonal antibody; 0.9% sodium chloride, same volume and same duration as CSL311
Other intervention name(s): CSL311
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Testing the Efficacy of the REThink Emotions Platform in a Full-scale SMART Study
Condition: Emotional Regulation
Study type: Interventional

Summary: 
      This activity will have the objective of testing the validity of the integrated in-game
      assessment and personalized REThinkEMOTIONS platform in the prevention of emotional disorders
      in youth.
    


Intervention name(s): REThink Game; MoodWheel; PsyPills
Intervention type(s): Other; Other; Other
Intervention description(s): REThink Game is the therapeutic game that uses psychological science to help youths find their superhero emotional strengths! It is composed of seven levels, each training a specific emotion regulation ability: emotion recognition, mindfulness and relaxation, cognitive change, positive bias, distinction between useful and useless thoughts, problem solving and compassion.; Mood Wheel is a web and mobile-based app that uses experience sampling procedures for the assessment of current/previous distress and positive emotions. The aim of the app is to inquire about the valence, control and functionality of users' emotions.; PsyPills is a self-help psycho-educational instrument intended to build stress resilience and to target (only) mild and transient negative mood states, alone or in combination with other methods/instruments.
Psychological Pills (PsyPills) are inspired by Rational-Emotive & Cognitive-Behavioral Therapy (CBT/REBT), which has strong evidence for its efficacy/effectiveness in human development/health promotion and in the treatment of a variety of psychological conditions.
The PsyPills app was tested in a pilot study and showed positive effects on reducing distress.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Phase 1 Study of BLB-201 Vaccine in Healthy Young and Older Adults
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 trial is an open-label trial to evaluate the safety, tolerability and
      immunogenicity of a single dose (10^7.5 PFU) of intranasal BLB-201 (a recombinant
      parainfluenza virus type 5) administered as a single dose in 15 healthy young adults ages
      18-59 years, and 15 older adults ages 60-75 years.
    

Detailed description: 
      This will be an open-label, age-escalation phase 1 trial of the PIV5 virus-vectored BLB-201
      vaccine in healthy adults (males and nonpregnant females) 18 to 59 years of age (Group 1),
      and 60 to 75 years of age (Group 2). The trial is designed to assess the safety,
      tolerability, and immunogenicity of a single dose of intranasal BLB-201 at 10^7.5 plaque-
      forming units (PFU) in both Group 1 and Group 2. The first 4 subjects in each group will be
      enrolled as sentinels and vaccination will proceed in a staged fashion.
    

Intervention name(s): CPI-RSV-F Vaccine (BLB-201)
Intervention type(s): Biological
Intervention description(s): see arm/group description
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Human respiratory syncytial virus (RSV); lower respiratory tract infection (LRTI)
The Expression of Matrix Metalloproteinase 13, Tissue Inhibitor of Metalloproteinases 3, and Calcium-sensing Receptor in Human Trabecular Meshwork
Condition: Open-angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Interventional

Summary: 
      This study was to assess the distinct expression of matrix metalloproteinase 13,tissue
      inhibitor of metalloproteinases 3, and calcium-sensing receptor, in human trabecular meshwork
      between normal and glaucomatous eyes.The expressions of matrix metalloproteinase 13, tissue
      inhibitor of metalloproteinases 3 and calcium-sensing receptor in the trabecular meshwork
      tissues were examined by streptavidin-peroxidase immunohistochemical staining method and
      western blot, and histological changes of trabecular meshwork were studied by Hematoxylin and
      Eosin staining.
    


Intervention name(s): trabeculectomy
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: matrix metalloproteinase 13; tissue inhibitor of metalloproteinases 3; calcium-sensing receptor; trabecular meshwork; open-angle glaucoma
Outcomes After Repair of Acute Rotator Cuff Tears
Condition: Rotator Cuff Tear
MeSH terms: Rotator Cuff Injuries
Study type: Observational

Summary: 
      Few studies are considering acute traumatic rotator cuff tears in previously asymptomatic
      patients. The purpose of the current study was to investigate if delay of surgery, age at
      repair and the number of cuff tendons involved affected the structural and clinical outcomes.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        A retrospective review of our computerized database identified 49 patients repaired at our
        institution between May 2004 until May 2009 due to acute traumatic rotator cuff tears. 42
        patients who fulfilled the inclusion criteria, were willing to participate in a follow-up
        evaluation after written and oral informed consent.
      
Keywords: rotator cuff tear; rotator cuff repair; age; timing to surgery
Study to Evaluate the Relative Abuse Potential of Almorexant in Recreational Drug Users
Condition: Abuse Potential Study
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a six-way crossover study with six single-dose treatment sessions. The profile of
      acute effects on abuse potential measures of different almorexant doses was compared to that
      of placebo and two doses of zolpidem
    

Detailed description: 
      This was a prospective, randomized, double-blind, double-dummy, balanced, placebo and
      active-controlled, six-way crossover Phase 1 study with six single-dose treatment sessions.
      The profile of acute effects on pharmacodynamic abuse potential measures of different
      almorexant doses was compared with that of placebo and two doses of zolpidem.
    

Intervention name(s): 200 mg almorexant; 400 mg almorexant; 1000 mg almorexant; 20 mg zolpidem; 40 mg zolpidem; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Almorexant; Zolpidem
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ODM-104 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of escalating doses of
      ODM-104 when given to healthy male volunteers.
    

Detailed description: 
      The study is divided into two parts. Part one is a crossover study where healthy volunteers
      will receive two doses of ODM-104 and one dose of placebo. Part II of the study is a multiple
      ascending dose parallel group study where healthy volunteers will receive ODM-104 three times
      daily for seven days. Healthy volunteers taking part in Part II of the study will also
      receive levo/carbidopa and entacapone four times daily on day 1 and levo/carbidopa in
      addition to ODM-104 on day 9. The study will also look at the pharmacokinetic(how the body
      handles the drug) and pharmacodynamics (how the drug affects the body) of ODM-104.
    

Intervention name(s): ODM-104; Placebo; Entacapone; levodopa/carbidopa
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): ODM-104; Placebo; entacapone + levodopa/carbidopa; entacapone + levodopa/carbidopa
Intervention MeSH terms: Levodopa; Carbidopa; Entacapone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: First in man study; Volunteer study
Study to Evaluate the Effects of RM-131 in Patients With Chronic Constipation
Condition: Chronic Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate safety and tolerability as well as the effects of
      RM-131 on colonic motor and sensory effects in patients with chronic constipation.
    


Intervention name(s): RM-131; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Double blind RM-131 (100 ug) will be delivered once by injection during study procedure.; Double blind placebo will be delivered once by injection during study procedure.
Other intervention name(s): relamorelin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: constipation
SR-45023A in Treating Patients With Locally Advanced or Metastatic Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase I trial to study the effectiveness of SR-45023A in treating patients who have
      locally advanced or metastatic solid tumors that have not responded to previous treatment.
    

Detailed description: 
      OBJECTIVES: I. Determine the maximum tolerated dose of SR-45023A in patients with locally
      advanced or metastatic solid tumors. II. Determine the quantitative and qualitative toxic
      effects of SR-45023A in these patients. III. Assess the plasma and urine pharmacokinetics of
      SR-45023A and relate these to drug effects, if possible, in these patients. IV. Determine any
      preliminary antitumor activity of SR-45023A in these patients.

      OUTLINE: This is a dose escalation study. Patients receive oral SR-45023A weekly. Treatment
      continues every 4 weeks in the absence of disease progression or unacceptable toxicity.
      Cohorts of 3-6 patients receive escalating doses of SR-45023A until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6
      patients experience dose limiting toxicity. Patients are followed for up to 1 month.

      PROJECTED ACCRUAL: A maximum of 36 patients will be accrued for this study.
    

Intervention name(s): apomine
Intervention type(s): Drug
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific
Comparative User Experiences With BD Nano™ PRO 4mm x 32G Extra Thin Wall Pen Needle vs Three Commercially Available Pen Needles
Condition: Diabetes
Study type: Interventional

Summary: 
      This is a subject partially blinded, block randomized, prospective, single-visit,
      multi-center study to compare user experiences with BD Nano™ PRO pen needle vs. three (3)
      thinner commercially available comparator pen needles (Artsana Insupen Extr3me 33G, Artsana
      Insupen Extr3me 34G and the Simple Diagnostics Comfort EZ™ 33G Pen Needles). The study will
      include up to 146 study subjects having Type 1 or Type 2 diabetes.
    

Detailed description: 
      The study will consist of one 60 to 120 minute visit in which pre-set doses of saline will be
      abdominally delivered by Subjects via a reusable insulin pen device. All pen needles will be
      attached by study staff. The pen needle outer cover and inner shield will be removed prior to
      subject use so that they will not be able to identify which device they are using. Subjects
      are to perform 12 injections into the abdomen (6 pairs of injections). Pairs of injections
      will be evaluated and each pair will contain one BD Nano™ PRO and one comparator pen needle.
      Within the 12 injections, each comparator will be injected twice, therefore each subject will
      experience 2 of each of the following pairs:

      BD Nano™ PRO pen needle vs Artsana Insupen Extr3me 4mm x 33G x 2 BD Nano™ PRO pen needle vs
      Artsana Insupen Extr3me 3.5mm x 34G x 2 BD Nano™ PRO pen needle vs Simple Diagnostics Comfort
      EZ™ 4mm x 33G Each Subject will evaluate pain after completion of each pair of injections
      using a 15 cm relative Visual Analog Scale (VAS).
    

Intervention name(s): BD Nano™ PRO; 33G Artsana Insupen Extr3me; 34G Artsana Insupen Extr3me; Simple Diagnostics Comfort EZ™
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Insulin Pen needle; Insulin Pen Needle; Insulin Pen Needle; Insulin Pen Needle
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: BD Nano (Test Device) will be compared to other currently marketed devices (controls) through a series of abdominal saline injections
Masking: Single (Participant)
Primary purpose: Other
Effects of Dexmedetomidine Premedication on Emergence Agitation After Strabismus Surgery in Children
Condition: Inhalational Anesthetics Adverse Reaction; Delirium on Emergence; Strabismus Following Ocular Surgery
MeSH terms: Strabismus; Emergence Delirium
Study type: Interventional
Phase: Phase 4

Summary: 
      Sevoflurane is frequently used for pediatric anesthesia because it has low pungency and rapid
      onset and offset of action.The reported incidence of emergence agitation (EA) following
      sevoflurane anesthesia varies from 10-80%. Despite its spontaneous resolution, EA is still
      considered as a potentially serious complication because of the risks of self-injury, and
      because of the stress caused to both caregivers and families.

      Dexmedetomidine, an Alpha2-adrenoceptor agonist with sedative, analgesic, and anxiolytic
      actions, has been used in pediatric populations.Several prospective clinical trials in
      children have shown that dexmedetomidine significantly reduces the incidence of EA prior to
      recovery from sevoflurane anesthesia. However, the effect of dexmedetomidine premedication on
      emergence agitation has not been fully evaluated. The purpose of the present study was to
      verify the hypothesis that intranasal premedication with dexmedetomidine is effective in
      reducing emergence agitation after sevoflurane anaesthesia.
    

Detailed description: 
      Emergence agitation was assessed using the Pediatric Anesthesia Emergence Delirium (PAED)
      scale.The PAED scale contains five items (eye contact, purposefulness of actions,awareness of
      surroundings, restlessness and consolability), each scored on a 0 to 4 scale, for a maximum
      of 20 points.

      A perfectly calm child scores 0 and extreme agitation corresponds to 20 points. The peak EA
      score was recorded. Agitation scores < 10 were interpreted as an absence of agitation,
      scores>= 10 were regarded as presence of agitation.
    

Intervention name(s): Dexmedetomidine; Midazolam; Saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The dexmedetomidine group received intranasal dexmedetomidine 2mcg/kg premedication 45 min before induction of anaesthesia.; The midazolam group oral midazolam 0.5 mg/kg 30 min before induction of anaesthesia.; The Placebo group received intranasal saline premedication 45 min and oral saline 30 min before induction of anaesthesia
Other intervention name(s): alpha2-adrenoceptor agonist; GABA modulators; sodium chloride injection (0.9%Nacl)
Intervention MeSH terms: Midazolam; Dexmedetomidine; GABA Modulators
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention