bioihbjkbjnl/mcl2 huggingface dataset:
Long-term Behavior Change - 1
Condition: Amphetamine-related Disorders
MeSH terms: Amphetamine-Related Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine if different reinforcement procedures (i.e.,
      schedules) produce different patterns of long-term abstinence from methamphetamine. We
      anticipate that the three contingency management conditions will promote longer periods of
      abstinence in the year following treatment relative to the standard control group.
      Furthermore, we predict that the intermittent reinforcement procedures will produce longer
      periods of continued abstinence (i.e., long-term behavior change) in the year following
      treatment than the continuous reinforcement procedure. Finally, we predict that the
      intermittent unpredictable schedule will produce longer lasting behavior change than the
      intermittent predictable schedule. Methamphetamine use will be measured using urine
      toxicology and self-report of methamphetamine use.
    

Detailed description: 
      Briefly the four study conditions are: (1) standard treatment which consists of 16 weeks of
      psychosocial treatment, (2) continuous contingency management which consists of 16 weeks of
      psychosocial treatment with a contingency management procedure in effect during the first
      twelve weeks in which vouchers are made available after each provision of a
      methamphetamine-negative urine test, (3) intermittent predictable contingency management
      which consists of 16 weeks of psychosocial treatment with a contingency management procedure
      in effect during the first twelve weeks in which vouchers are available after the provision
      of every three consecutive methamphetamine-negative urine samples, and (4) intermittent
      unpredictable contingency management which consists of 16 weeks of psychosocial treatment
      with a contingency management procedure in effect during the first twelve weeks in which
      vouchers are available on one day each week (randomly selected after the first week) for the
      provision of methamphetamine-negative urine samples provided all urine samples since delivery
      of the last reinforcer were also methamphetamine negative.
    

Intervention name(s): contingency management voucher
Intervention type(s): Behavioral
Intervention description(s): participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adherence; Amphetamine-Related Disorders; Behavior Therapy; Contingency management; Drug Counseling; health behaviors; methamphetamine; sexual risk behaviors; substance dependence
Phase I Study to Evaluate the Safety of Dexibuprofen 200mg Under Fasting and Fed Conditions
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I Study to Evaluate the Safety of Dexibuprofen 200mg (Apsen Pharmaceuticals A / S.)
      After a Single and Multiple Dose Oral Administration in Healthy Participants of Both Sexes
      Under Fasting and Fed Conditions.
    

Detailed description: 
      A single oral dose of test medicine will be administered to participants in a practical
      period with the aid of 200 mL of water at room temperature. During administration,
      participants should stay in seated position. Participants will be confined at least 12 hours
      prior to administration and will remain for about 24 hours after the same, totaling about 36
      hours of confinement.

      After 36 hours of confinement the participantes will proceed to the multi-dose use phase for
      seven days in fed conditions.

      To assess safety, an evaluation of the vital signs, laboratory tests and health status of the
      participants will be carried out throughout the study.
    

Intervention name(s): Dexibuprofen
Intervention type(s): Drug
Intervention description(s): Dexibuprofen 200 mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
National Cooperative Growth Study (NCGS) of Optimal Nutropin AQ and Nutropin Dosing in Pubertal Growth Hormone-Deficient (GHD) Patients
Condition: Dwarfism, Pituitary
MeSH terms: Dwarfism; Dwarfism, Pituitary
Study type: Observational

Summary: 
      This study is a multicenter, open-label, observational, postmarketing surveillance study that
      will collect information on the use of Genentech GH preparations to treat GH-deficient
      subjects with optimal GH dosing during puberty.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Pubertal Growth Hormone Deficiency
      
Keywords: Pubertal Growth Hormone Deficiency
A Study to Evaluate the Effects of Once Daily Doses of AQW051 on Cognition, in Stable Schizophrenia Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study in chronic stable Schizophrenia with the purpose to answer the question of
      whether agonism of the nicotinic alpha7 receptor is capable of enhancing cognition in a well
      defined chronic stable patient population treated with antipsychotics as standard of care,
      and thus to support the future development of AQW051 for the treatment of cognitive
      impairment associated with Schizophrenia (CIAS).
    


Intervention name(s): AQW051; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: schizophrenia, chronic stable schizophrenia, cognition, memory, visual learning, CogState
A Study of Encapsulated Cell Technology (ECT) Implant for Patients With Late Stage Retinitis Pigmentosa
Condition: Retinitis Pigmentosa
MeSH terms: Retinitis; Retinitis Pigmentosa
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to look at the safety and effectiveness of CNTF implants on
      vision in persons with retinitis pigmentosa, Usher type II & III, and Choroideremia. This
      research is being done because there are no effective therapies for people with these retinal
      degenerations. They are genetic disorders that affect our ability to see at night, and later
      cause tunnel vision and loss of central vision. Retinal degenerations affect the retina, a
      light sensitive layer of cells in the back of the eye. Slowly over time, these cells die and
      cause permanent loss of vision.

      The implant is a small capsule that contains human retinal pigment epithelium cells. These
      cells have been given the ability to make CNTF and release it through the capsule membrane
      into the surrounding fluid. This study will look at the effect of the implant on vision loss
      by retinitis pigmentosa, Usher type II & III, and Choroideremia. In this study, two different
      CNTF dose levels will be used: a high dose and a low dose in one eye, as well as a sham (or
      placebo) surgery in the other eye.
    

Detailed description: 
      This study will involve about 16 visits over 1½ years for specific tests of the participant's
      vision and health. These visits may include visual exams, blood draw for laboratory testing,
      brief medical history and exam, and occasionally a questionnaire (survey), in addition to the
      visit for the surgical procedures. The primary effectiveness outcome for this study will be a
      visual acuity score one year after the implant surgery. There will be about 13 centers
      participating in this study, and up to 60 people enrolled across the US. Each participant
      joining the study who has completed initial screening will then be scheduled to have a brief
      surgical procedure performed on each eye, one of which will include a very small cell-filled
      implant. Follow-up visits for repeat assessments will be required regularly to determine if
      the implant being tested is safe and effective for use to treat RP.
    

Intervention name(s): NT-501; NT-501
Intervention type(s): Drug; Drug
Intervention description(s): High Dose; Low Dose
Other intervention name(s): CNTF implant; CNTF implant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Retinitis Pigmentosa; eye disease; retinal disorder; CNTF
Low-dose Computed Tomography-guided Core Needle Biopsy for Lung Nodules
Condition: Lung Cancer; Lung; Node
Study type: Interventional

Summary: 
      Investigators aim to compare the diagnostic accuracy and radiation exposure between low-dose
      and standard-dose computed tomography-guided core needle biopsy for lung nodules.
    

Detailed description: 
      At present, low-dose scanning protocol is widely used in computed tomography-guided
      interventions because these procedures usually require repeat scans, which causes more
      radiation exposure to the patients. Computed tomography-guided core needle biopsy is widely
      used in diagnosis of lung nodules with an overall diagnostic accuracy of 93%-97%. Compared
      with the large lung lesions, computed tomography-guided core needle biopsy for lung nodules
      might require more scanning to adjust the position of needle tip. Therefore, it might expose
      the patients to more radiation. However, studies regarding computed tomography-guided core
      needle biopsy for lung nodules are still lacking.

      In this study, investigators aim to compare the diagnostic accuracy and radiation exposure
      between low-dose and standard-dose computed tomography-guided core needle biopsy for lung
      nodules.
    

Intervention name(s): Low-dose computed tomography; Standard-dose computed tomography
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Radiation dose under the low-dose protocol computed tomography (120 kilovolt, 15 milliampere seconds); Radiation dose under the standard-dose protocol computed tomography (120 kilovolt, 150 milliampere seconds)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Effect of Succinylcholine on Patients Using Statins
Condition: Pain
Study type: Interventional

Summary: 
      Based on available mechanistic and clinical information, the investigators propose a
      nonrandomized study to evaluate the effect of succinylcholine in patients taking statins. The
      investigators' purpose is to evaluate the effect of succinylcholine on patients taking
      statins. Patients scheduled to undergo elective surgery (other then orthopedic, spinal,
      vascular or muscle) with planned endotracheal intubation will be approached regarding
      participation in the trial. Design of the study is complex because there is no way to
      randomize patients to statins or no statins and also no way to take them off the statins
      prior surgery. So statin use will not be randomized; confounding factors will be accounted
      for by stratification (every 10 years of age from 40-80 and gender) and statistical
      adjustment. The investigators propose to test the hypothesis that succinylcholine
      administration increases plasma myoglobin concentration more in patients who are on statins
      compared to patients who do not.
    


Intervention name(s): Succinylcholine
Intervention type(s): Drug
Intervention description(s): Succinylcholine will be administered pre-induction over a period of 5 seconds
Intervention MeSH terms: Succinylcholine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Succinylcholine; Statins; myalgias; statins with succinylcholine and pain
Safety of and Immune Response to a Tick-Borne Encephalitis Vaccine (LGT(TP21)/DEN4) in Healthy Adults
Condition: Tick-Borne Encephalitis
MeSH terms: Encephalitis, Tick-Borne; Encephalitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Tick-borne encephalitis (TBE) is a viral illness common in the Northern Hemisphere,
      especially Europe and Asia. TBE infection may lead to central nervous system problems and
      death. The purpose of this study is to test the safety of and immune response to a TBE
      vaccine in healthy adults. The vaccine is related to a live attenuated virus developed
      against dengue virus infection.
    

Detailed description: 
      TBE is a common illness in Europe and Asia, where it is usually associated with mild illness
      but sometimes leads to long-term symptoms and even death. This study will evaluate the safety
      and immunogenicity of a live attenuated chimeric virus, LGT(TP21)/DEN4, which is derived from
      the Langat flavivirus and DEN4 dengue virus serotypes.

      Each volunteer will be involved in the study for 180 days. Participants in Cohort 1 will be
      randomly assigned to receive LGT(TP21)/DEN4 or placebo at study entry. Cohort 2 will begin
      only after safety review of all participants in Cohort 1. Participants in Cohort 2 will
      receive a higher dose of LGT(TP21)/DEN4 or placebo.

      After vaccination, participants will be asked to monitor their temperatures every day for 16
      days and on Day 19. Study visits will occur every other day after vaccination until Day 16,
      followed by 5 additional visits at selected days through Day 180. Blood collection and a
      targeted physical exam will occur at each study visit. Some participants will be asked to
      undergo a skin biopsy or additional blood collection at selected visits.
    

Intervention name(s): LGT(TP21)/DEN4; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Live attenuated LGT(TP21)/DEN4 vaccine (one of two doses); Placebo for LGT(TP21)/DEN4 vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Dengue Vaccine; Tick-Borne Illnesses; Flavivirus
The Effect of Gastric Bypass Surgery on the Glucose Metabolism Seen in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Gastric bypass surgery has in many studies shown total remission of type 2 diabetes as early
      as 1 - 2 days after surgery and this is before any real weight loss has occurred. This
      suggest that the remission of the diabetes is due to the direct effect of the operation more
      that the secondary effect of the weight loss. The reason for the major effect on the glucose
      metabolism after gastric bypass surgery is still unaccounted for.

      This PhD. project will try to unveil some of the mechanisms that could explain the effect of
      gastric bypass surgery on the glucose metabolism seen in patients with type 2 diabetes.

      The hypothesis of the study is that a factor "X" will course the remission of the diabetes.
      This factor "X" is related to the anatomic changes of the gastro intestinal tract, by
      eliminating the foods passage through the distal part of the ventricle and the duodenum, in
      combination with the Roux- en-Y sling.

      The PhD. project will consist of clinical trails on patients that will undergo gastric bypass
      surgery. The studies will take place before and within the 1. week after surgery. The
      investigators will measure different hormones and adipokines in fast and the postprandial
      state. To discover possible new proteins the investigators will run proteomic on some
      samples. All the results will be compared to the same parameter on patients undergoing
      gastric banding, where the anatomy of the intestine hasn't been changed.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patiens undergoing gastric bypass surgery with or without type 2 diabetes and patients with
        diabetes undergoing gastric banding
      
Biospecimen description: 
      Blood samples
    
Keywords: Diabetes; gastric bypass; type 2 diabetes and gastric bypass
Dose Proportionality Study Comparing Amaryl-M 1/500 mg and Amaryl-M 2/500 mg
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The pharmacokinetics of glimepiride and metformin HCl will be compared after single dose
      intake of both combinations in order to answer the following questions:

        -  Is Amaryl-M 1/500 mg (Test tablet) proportional to Amaryl-M 2/500 mg tablet with regard
           to the glimepiride component?

        -  Is Amaryl-M 1/500 mg (Test tablet) tolerable comparing with Amaryl-M 2/500 mg?
    

Detailed description: 
      16 subjects were randomized to each of 2 sequence groups which have different treatment order
      of the study drug in each period.

      Only healthy volunteers had screening tests such as medical inquiry, physical examination,
      clinical laboratory test, etc. within 4 weeks (-28d ~ -1d) prior to drug administration (1d)
      and those determined eligible for this study were selected and randomized between screening
      and 1 day prior to the first administration of study medication (-1d). Then, the subjects
      were admitted to the clinical research center of Seoul National University Hospital by 9 p.m.
      of -1d and then, they were not allowed to take anything except water.

      After one week of washout period, subjects went on to the second phase of treatment period
      and were administered according to the treatment order in a crossover way. For the subjects
      who completed the study, post-study visit tests were performed after a designated time had
      passed.
    

Intervention name(s): Amaryl-M 2/500 mg; Amaryl-M 1/500 mg
Intervention type(s): Drug; Drug
Intervention description(s): single oral administration in period 2 for TR sequential group, and in period 1 for RT sequential group, respectively; single oral administration in period 1 for TR sequential group, and in period 2 for RT sequential group, respectively
Other intervention name(s): glimepiride 2 mg & metformin HCl 500 mg; glimepiride 1 mg & metformin HCl 500 mg
Intervention MeSH terms: Metformin; Glimepiride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Volunteer
Radioimmunoimaging of AL Amyloidosis
Condition: AL Amyloidosis
MeSH terms: Immunoglobulin Light-chain Amyloidosis; Amyloidosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive
      monoclonal antibody to document the presence and distribution of amyloid deposits by PET/CT
      imaging in patients with AL amyloidosis.
    

Detailed description: 
      To be eligible for this study, patients must have a confirmed diagnosis of AL amyloidosis
      without significant cardiac (New York Heart Association class IV) disease and not be on
      kidney dialysis. Additionally, after testing, their blood must not contain antibodies to
      mouse proteins. The study requires an intravenous infusion, over 10 minutes, of the
      radiolabeled antibody, followed 48 hours later by a PET/CT scan. A repeat scan is done 5 or 7
      days after infusion of the antibody. A 5 ml blood specimen needs to be furnished 4 and 8
      weeks after the antibody infusion.
    

Intervention name(s): 124I-labeled monoclonal antibody Mu 11-1F4
Intervention type(s): Biological
Intervention description(s): Single infusion of radiolabeled antibody: 2mCi (1 mg)
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Radioimmunoimaging; AL Amyloidosis; PET/CT
Open-Label Extension Study to Evaluate the Safety, Tolerability and Activity of Oral Fampridine-SR in Patients With Multiple Sclerosis Who Participated in the MS-F204 Trial
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate the safety, tolerability and activity of
      Fampridine-SR when administered for up to 36 additional months in patients who previously
      participated in the MS-F204 study or until it becomes commercially available, whichever comes
      first.
    

Detailed description: 
      Multiple sclerosis (MS) is a disorder of the body's immune system that affects the central
      nervous system (CNS). Normally, nerve fibers carry electrical impulses through the spinal
      cord, providing communication between the brain and the arms and legs. In people with MS, the
      fatty sheath that surrounds and insulates the nerve fibers (called "myelin") deteriorates,
      causing nerve impulses to be slowed or stopped. As a result, patients with MS may experience
      periods of muscle weakness and other symptoms such as numbness, loss of vision, loss of
      coordination, paralysis, spasticity, mental and physical fatigue and a decrease in the
      ability to think and/or remember. These periods of illness may come (exacerbations) and go
      (remissions). Fampridine-SR is an experimental drug that has been reported to possibly
      improve muscle strength and walking ability for some people with MS. This study will evaluate
      the effects and possible risks of taking Fampridine-SR in MS patients over a long period of
      time.
    

Intervention name(s): Fampridine-SR
Intervention type(s): Drug
Intervention description(s): Tablets, 10 mg, BID (twice daily)
Other intervention name(s): 4-aminopyridine
Intervention MeSH terms: 4-Aminopyridine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: multiple sclerosis; MS; walking; leg strength; demyelination
Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy
Condition: Narcolepsy
MeSH terms: Narcolepsy; Sleepiness
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objectives: The primary objectives of the study are to determine the effectiveness of
      PROVIGIL treatment, compared to placebo treatment, in children and adolescents with excessive
      sleepiness (ES) associated with narcolepsy, as assessed by:

        -  mean sleep latency from the Multiple Sleep Latency Test (MSLT) (average of 4 naps
           performed at 0900, 1100, 1300, and 1500) at the last post-baseline observation (week 6
           or early termination)

        -  the Clinical Global Impression of Change (CGI-C) ratings for ES, at the last
           post-baseline observation (week 6 or early termination).
    


Intervention name(s): Modafinil
Intervention type(s): Drug
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Pediatric Narcolepsy; Excessive sleepiness